Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000643673
Ethics application status
Approved
Date submitted
21/05/2023
Date registered
14/06/2023
Date last updated
14/06/2024
Date data sharing statement initially provided
14/06/2023
Date results information initially provided
14/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing a model of Neonatal Nurse Controlled Analgesia (NNCA) to manage post-operative pain in the surgical neonate.
Scientific title
Pilot testing a model of Neonatal Nurse Controlled Analgesia (NNCA) to manage post-operative pain in the surgical neonate.
Secondary ID [1] 309667 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PAINS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 330014 0
Condition category
Condition code
Anaesthesiology 326924 326924 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Path A (less than12hrs post-operative)
Infants will commence on pathway A on return from theatre.
• Depending on if the infant is already receiving an opioid infusion prior to surgical intervention and/ or amount of analgesia administered intra-operatively, consideration of a loading dose of morphine will occur on return to the neonatal unit following a medical review.
• Nursing staff will administer a bolus of 25micrograms/kg of morphine every 15minutes during first hour post-operatively to a maximum of 75mircograms/kg to achieve a modified pain assessment tool (MPAT) score equal to or less than 4. If three boluses are needed, increase the infusion rate by 5micrograms/kg/hr.
• IV Paracetamol 7.5mg/kg to be commenced within 2hrs of commencing on Pathway A if not administered to infant in the previous 6hrs.
• Reassess infant MPAT pain score in 60mins.
• If achieving a MPAT score less than or equal to 4, the infant will use LOW pathway.
• If MPAT scores are between 5 and 9, the infant will use MOD pathway.
• If MPAT scores are greater than or equal to 10, the infant will use SEV pathway.
• If after 12hours, infant achieving MOD scores or lower, transition to Path B. If scores are in the SEV range, continue on Path A until MOD scores are achieved or Neonatal Nurse Controlled Analgesia (NNCA) is suspended as per designated pathway.

LOW pathway
1. Continue current rate of morphine infusion.
2. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
3. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs.
4. Reassess pain scores using MPAT every 60mins.
5. One cycle is steps 1-4.
6. If MPAT scores remains equal to or less than 4, continue management as per steps 1-4.

MOD pathway
1. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
2. Explore other potential sources of pain or discomfort.
3. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs.
4. Reassess MPAT scores every 30-60mins.
5. One cycle constitutes steps 1-4.
6. If MPAT score remains in this range after 30-60mins, complete steps 1-4 again
7. If after completing two cycles through this pathway a medical review is required.
8. Increase morphine infusion by 5microgs/kg/hr and reassess in 30-60mins. (Morphine must not exceed 15microgs/kg/hr for non-intubated infants and 20microgs/kg/hr for intubated infants on the MOD pathway.
9. If MPAT score remains in the MOD range, continue on this pathway, progressing through each cycle.
10. If infant requires morphine > 20microgs/kg/hr, infant to escalate to the SEV pathway.
11. If morphine does not exceed defined limits for the MOD pathway, transition to Path B after 12hours postoperative.

SEV pathway
1. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
2. Explore other potential sources of pain or discomfort.
3. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs.
4. Administer bolus of 25microg/kg of morphine every 15mins up to a maximum of 75micros/kg in a four-hour period as required.
5. Consider a medical review.
6. Reassess MPAT score in 30-60mins.
7. One cycle constitutes steps 1-6.
8. If MPAT pain scores remains in SEV range after completing two cycles through pathway, increase morphine by 5microgs/kg/hr and reassess MPAT score in 30-60mins.
9. If MPAT score remains in SEV range after completing three cycles through pathway, a medical review is required. Consideration for increasing morphine infusion by 5microgs/kg/hr. Reassess MPAT score 30-60mins.
10. If MPAT score remains in SEV range after completing four cycles through pathway, increase morphine by 5micros/kg/hr.
11. If non-intubated infants require a morphine infusion > 15microgs/kg/hr, a medical review is required and possible need for intubation.
12. Reassess MPAT score 30-60min.
13. If four cycles through the SEV pathway, increase morphine by 5microgs/kg/hr.
14. A medical review is required.
15. If intubated infants require a morphine infusion >30microgs/kg/hr, consider the commencement of dexmedetomidine at 0.2-0.3microgs/kg/hr if appropriate to the local context.
16. Reassess MPAT score 30-60mins
17. If MPAT score remains in SEV range despite the use of morphine at 30microgs/kg/hr and dexmedetomidine at 0.3microgs/kg/hr, the NNCA model will be suspended and the infant’s analgesic needs will be managed as per treating team according to clinical and analgesic needs of the infant.

Path B (12hrs to 5 days post-operative)
• If achieving a MPAT score less than or equal to 4, the infant will use LOW pathway.
• If MPAT scores are between 5 and 9, the infant will use MOD pathway
• If MPAT scores are greater than or equal to 10, the infant will use SEV pathway

LOW pathway
1. Wean opioid rate by 20% of highest dose every 4-6hours until ceased.
2. Once opioid infusion ceased, reassess need for continuation of regular paracetamol.
3. Reassess MPAT score every 60mins for 24hrs post-operatively.
4. One cycle constitutes steps 1-3.
5. If MPAT score remains in this LOW range after this time, reassess MPAT scores every 2-4hrs until all analgesics ceased for 48hours.
6. If infant had been receiving dexmedetomidine and MPAT scores remain less than or equal to 4, consider ceasing without weaning if infusing for less than 24hrs.
7. If dexmedetomidine infusing for greater than 24hours, reduce rate by 50%. If well tolerated, cease infusion in 4-6hours after halving dose.
MOD pathway
1. Pause/do not commence weaning.
2. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
3. Assess for other contributing factors.
4. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs.
5. Reassess pain score using MPAT every 30- 60mins.
6. One cycle constitutes steps 1-5.
12. If MPAT score remains in MOD range after 30-60mins, complete steps 1-5 again
13. If after completing two cycles through this pathway, consider returning analgesia to previous dose if weaning commenced.
14. If MPAT score remains in MOD range after completing three cycles through the pathway, return analgesia to previous dose if not done in step 13. If dose had been increased in step 13, request medical review and consider commencement of dexmedetomidine infusion at between 0.2-0.3microgs/kg/hr. Reassess MPAT score in 30-60mins and progress through steps 1-4 again.
15. If MPAT score remains in MOD range after completing four cycles through pathway, return to Path A and request a medical review.

SEV pathway
1. Pause/do not commence weaning.
2. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
3. Assess for other contributing factors.
4. Administer intravenous paracetamol (7.5mg/kg) if not given in previous 6 hrs.
5. Reassess pain score using MPAT every 30- 60mins.
6. One cycle constitutes steps 1-5.
7. If MPAT pain score remains in MOD range after 30-60mins, progress through steps 1-5 again.
8. If after completing two cycles through this pathway, request medical review and return to Path A for continued assessment and management.

Path C (equal to or greater than5 days post-operative)
• If withdrawal assessment tool (WAT-1) score less than or equal to 3 and MPAT score less than or equal to 4, the infant will use green pathway.
• If WAT-1 score is less than or equal to 3 and MPAT score equal to or greater than 5, infant will use pink pathway.
• If WAT-1 score is equal to or greater than 3 and MPAT score is equal to or less than 4, infant will use purple pathway.
• If WAT-1 score is equal to or greater than 3 and MPAT score is equal to or greater than 5, infant will use blue pathway.

Green pathway
1. Wean opioid rate by 20% of highest dose daily until opioid ceased or changed to enteral therapy as per treating medical team.
2. Reassess MPAT score every 2-4hrs and WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse.

Pink pathway
1. Do not wean.
2. Maintain current opioid rate.
3. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
4. Consider medical review.
5. Reassess MPAT score every 2-4hrs and WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse.
6. Reassess eligibility to wean opioid in 4-6hours.
7. One cycle constitutes steps 1-5.
8. If after completing two cycles through this pathway, request medical review.
9. Consideration for increasing opioid dose back to previous rate or administering hourly rate as a bolus.
10. If rate increased back to previous dose, maintain this rate for 24hours before considering further wean.
11. Continue to WAT-1 scores every 12hours. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse.
12. If after completing three cycles through this pathway, request medical review.
13. If WAT-1 scores remain in this range, despite increase in rate or previous bolus dose, discontinue NNCA and manage IWS as per treating medical team.

Purple pathway
1. Do not wean.
2. Maintain current opioid rate.
3. Assess for other contributing factors.
4. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
5. Consider medical review.
6. Reassess WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse.
7. Reassess MPAT score in 2-4hours
8. One cycle constitutes steps 1-7.
9. If after completing two cycles through this pathway, request medical review.
10. If MPAT pain score remains in the LOW range , consider weaning opioid rate by 10% of the highest dose once per day.
11. Continue to reassess MPAT pain score in 2-4hours. MPAT scoring may be completed more frequently at the discretion of the primary care nurse.
12. If after completing three cycles through this pathway, request medical review.
13. If MPAT scores remain in the LOW range but WAT-1 scores continue to be equal to or greater than 3, consider changing to enteral therapy and treating as per neonatal team.


Blue pathway
1. Do not wean.
2. Maintain current opioid rate.
3. Assess for other contributing factors.
4. Encourage parental presence and the administration of non-pharmacological measures. Parents and staff will administer these measures as appropriate based on individualized needs of infant. Parents will receive information on the administration of these strategies following randomization into the treatment arm. These measures may include: decrease environmental stimulus by shielding eyes from direct light, not talking over infant, use of eye shades or ear muffs as appropriate, containment using boundaries, a wrap, and/or hand hugs, swaddling as appropriate (dependent on clinical condition and surgical repair site), facilitated tucking and positioning, maternal/paternal voice, non-nutritive sucking with pacifier (with parental consent), scent hearts (maternal/paternal scent) if appropriate, positive touch, nappy changes and possibly
skin to therapy (as appropriate with consideration of type of surgery and time elapsed.
5. Consider medical review.
6. Reassess WAT-1 score every 12hrs. WAT-1 scoring may be completed more frequently at the discretion on the primary care nurse.
7. Reassess MPAT score in 60mins.
8. One cycle constitutes steps 1-7.
9. Request a medical review.
10. If after completing two cycles through this pathway, increase opioid rate to previous dose and or administer hourly rate as a bolus.
11. If opioid rate increased, maintain rate for 24hours before considering further wean.
12. Reassess MPAT score in 60mins.
13. If after completing three cycles through this pathway, request medical review.
14. Consider opioid increase or administration of hourly rate as a bolus.
15. Reassess MPAT score in 60mins.
16. If after completing four cycles through this pathway and WAT-1 scores and MPAT pain scores remain in this range, discontinue NNCA and manage as per treating medical team.




Intervention code [1] 326103 0
Treatment: Other
Comparator / control treatment
Following return to the neonatal intensive care unit form the operating theatre, participants randomised to the control group will continue the same regime as is per usual post-operative analgesic management. There is no current guideline or standardisation for neonatal post-operative pain relief and clinical management of analgesia is dependent on Neonatologist/treating medical team on service. Titration and weaning of analgesia is completed following review/discussion with MO/NNP. Pain scores, using the MPAT tool may be used to help guide the decision to titrate analgesia weaning.
Control group
Active

Outcomes
Primary outcome [1] 334755 0
Number of infants meeting the inclusion criteria and eligible for recruitment within the study period. This will be done for each 24 hr period retrospectively once recruitment commences by the lead researcher using the neonatal electronic data base. Progression criteria to a larger trial will use a traffic light system using mean score. Green = No changes. May proceed to larger trial, Amber = Modify before proceeding and Red= Modify/Stop.
Green = 80%
Amber =50%
Red <50%
Timepoint [1] 334755 0
End of study
Primary outcome [2] 334756 0
Number of infants recruited into the study. This will be determined by study records. Progression criteria to a larger trial will use a traffic light system using mean score. Green = No changes. May proceed to larger trial, Amber = Modify before proceeding and Red= Modify/Stop.
Green = 80%
Amber =50%
Red <50%
Timepoint [2] 334756 0
Following recruitment of 26 proposed participants (13 in each arm of trial)
Primary outcome [3] 334757 0
Compliance with the trial intervention (Adherence to model of NNCA). This will be determined by retrospectively reviewing medical records for each 24hr period and by reviewing NNCA documentation for any noted variances. Progression criteria to a larger trial will use a traffic light system using mean score. Green = No changes. May proceed to larger trial, Amber = Modify before proceeding and Red= Modify/Stop.
Green = 75%
Amber =50%
Red <50%
Timepoint [3] 334757 0
Until all analgesic pharmacological agents have been ceased for 48hours.
Secondary outcome [1] 421977 0
Intensity of pain scores as measured by validated MPAT (modified Pain Assessment Tool)
Timepoint [1] 421977 0
Frequency of pain assessment is completed by the primary care nurse and is based on individual scores and behaviours, analgesic administration, time since surgery, parental concern. Intensity of pain scores will be measured retrospectively for each 24hr period from admission to discharge of patient.
Secondary outcome [2] 421978 0
Overall opioid consumption measured in micrograms. This data will be provided by patient medical records and will be retrospectively collected for each 24hr period.
Timepoint [2] 421978 0
Until cessation of opioids.
Secondary outcome [3] 421979 0
Time on invasive ventilation measured by number of hours participant was intubated. This data will be provided form patient medical records. It will be retrospectively collected for each 24hr period.
Timepoint [3] 421979 0
From admission to discharge
Secondary outcome [4] 421980 0
Parental satisfaction score measured using the Parent attitudes about infant nociception (PAIN) tool.
Timepoint [4] 421980 0
Prior to participant discharge
Secondary outcome [5] 421981 0
Length of Stay measured by number of days participant was admitted to the neonatal unit. This information will be obtained from patient medical records.
Timepoint [5] 421981 0
Until time of discharge
Secondary outcome [6] 421983 0
Adverse events including but not limited to apnoea or need for intubation/re-intubation if receiving analgesics as per guidelines. Hypotension considered medically not to be associated with acute fluid loss or post-operative third spacing. Adverse events will be assessed using :
Apnoea- documented on standard adverse clinical events chart and or need for intubation
Hypotension - Decrease in blood pressure parameters requiring intervention. This is individualised and will be determined by medical team caring for infant.
Timepoint [6] 421983 0
Until time to discharge
Secondary outcome [7] 421985 0
Time to receiving full enteral feeds.
Timepoint [7] 421985 0
Until participant receiving and tolerating complete enteral nutrition. This data will be obtained from patient chart and collected retrospectively for the previous 24 hr period
Secondary outcome [8] 421986 0
Time to cessation of all analgesics
Timepoint [8] 421986 0
Until all analgesics ceased following surgical intervention. This will be determined by patient medical records. Data will be collected retrospectively for the previous 24hr period
Secondary outcome [9] 421988 0
Iatrogenic Withdrawal scores >3 as measured by WAT-1 tool.
Timepoint [9] 421988 0
Until 48 hours cessation of all analgesic medications. This data will be taken from WAT-1 clinical chart that is commenced from day 5 of opioid use. This will be collected retrospectively for each 24hour period.
Secondary outcome [10] 422374 0
Pharmacological management of Iatrogenic withdrawal syndrome
Timepoint [10] 422374 0
Until 48hrs post cessation of all analgesic medication. This information will be obtained from the patient chart and retrospectively collected for each 24hr period
Secondary outcome [11] 422379 0
Staff acceptability of the NNCA model will be determined by a researcher developed survey using a 5-point Likert scale where 1=strongly agree to 5 =strongly disagree. Questions will focus on use of the tool, impact on practice, perceived benefit, promotion of nurse autonomy and strengths and limitations. This survey will be completed using implied consent. The link to the survey will be emailed to all staff in the clinical area trialling the model at the end of the study period.
Timepoint [11] 422379 0
End of the study period
Secondary outcome [12] 422890 0
Number of parent surveys completed.
Timepoint [12] 422890 0
At time of infant discharge

Eligibility
Key inclusion criteria
Infants greater than 35 weeks gestation PMA,
Infants requiring a surgical operation,
Infants not requiring other pharmacological agents to manage haemostability,
Opioid naïve infants or infants commenced on opioids for the first time within the previous 48hrs,
Infants able to be cared for in a 1:1 allocation for the first 24hrs post-operatively.
Infants in which a parent is present and able to provide informed consent.
Minimum age
0 Hours
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with any Illness complicated by physical instability (e.g. Persistent Pulmonary Hypertension of the Newborn) in which additional sedation/muscle relaxation is required to manage clinical condition.
Infants with complex surgical conditions (as determined by treating neonatologist)
Infants with impaired hepatic or kidney function/Unconjugated hyperbilirubinaemia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a feasibility pilot study, no power calculation has been performed. Categorical data will be described using frequencies and percentages and continuous data using, mean and standard deviation for normally distributed data and median and interquartile range for non-normally distributed data. The comparison of interest is between NNCA and standard care. Categorical variables will be examined using Pearson’s Chi-squared test or Fisher’s exact test where more than 20% of the expected values are less than 5. Continuous variables will be examined using Student t-test or Mann Whitney U test if data is not normally distributed. P values <0.05 will be considered statistically significant. Further acceptability of the NNCA model will be determined by a researcher developed survey using a 5-point Likert scale where 1=strongly agree to 5 =strongly disagree. Questions will focus on use of the tool, impact on practice, perceived benefit, promotion of nurse autonomy and strengths and limitations.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Feasibility outcome data sufficient to determine acceptability of model and whether progression to larger trial warranted.
Date of first participant enrolment
Anticipated
26/06/2023
Actual
20/06/2023
Date of last participant enrolment
Anticipated
29/12/2023
Actual
16/04/2024
Date of last data collection
Anticipated
26/01/2024
Actual
25/04/2024
Sample size
Target
26
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24756 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 40383 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 313860 0
Charities/Societies/Foundations
Name [1] 313860 0
Betty McGrath seeding scholarship sponsored by Mater Research and Mater Foundation.
Country [1] 313860 0
Australia
Primary sponsor type
Individual
Name
Renee Muirhead
Address
Neonatal Critical Care Unit
Mater Mothers' Hospital,
Raymond Terrace
South Brisbane, QLD. 4101
Country
Australia
Secondary sponsor category [1] 315690 0
Individual
Name [1] 315690 0
Peter Lewis
Address [1] 315690 0
University of Queensland
School of Nursing, Midwifery and Social Work
Mater Hospital Campus; Whitty Building,
Level 3, Chamberlain Building, The University of Queensland 4072
Country [1] 315690 0
Australia
Secondary sponsor category [2] 315695 0
Individual
Name [2] 315695 0
Kathryn Kynoch
Address [2] 315695 0
Clinical Governance Unit,
Mater Health
14 Stratton Street, Newstead. QLD, 4006
Country [2] 315695 0
Australia
Secondary sponsor category [3] 315696 0
Individual
Name [3] 315696 0
Ann Peacock
Address [3] 315696 0
University of Queensland
School of Nursing, Midwifery and Social Work
Mater Hospital Campus; Whitty Building,
Level 3, Chamberlain Building, The University of Queensland 4072
Country [3] 315696 0
Australia
Secondary sponsor category [4] 315697 0
Individual
Name [4] 315697 0
Pita Birch
Address [4] 315697 0
Neonatal Critical Care Unit
Mater Mothers' Hospital,
Raymond Terrace
South Brisbane, QLD. 4101
Country [4] 315697 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313007 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 313007 0
Raymond Terrace, South Brisbane
QLD. 4101
Ethics committee country [1] 313007 0
Australia
Date submitted for ethics approval [1] 313007 0
01/02/2023
Approval date [1] 313007 0
08/05/2023
Ethics approval number [1] 313007 0
HREC/MML/94314 (V5)
Ethics committee name [2] 313012 0
University of Queensland Human Ethics Committee
Ethics committee address [2] 313012 0
Research Ethics and Integrity Office
The University of Queensland
St Lucia.
Brisbane, QLD. 4072
Ethics committee country [2] 313012 0
Australia
Date submitted for ethics approval [2] 313012 0
10/05/2023
Approval date [2] 313012 0
10/05/2023
Ethics approval number [2] 313012 0
2023/HE000939

Summary
Brief summary
A model of neonatal nurse-controlled analgesia (NNCA) to manage neonatal surgical pain has been developed. This model was informed through the literature, the results of a systematic review, a survey of current Australasian neonatal pain practices and an expert panel of neonatal clinicians/researchers with knowledge/expertise of pain assessment and management practice across Australia and New Zealand. The final model of this NNCA will be tested in the Cardiac/surgical neonatal intensive care unit (C/S:NCCU) of the Mater Mothers’ Hospital South Brisbane. This pilot trial will be a randomised controlled trial to test the feasibility of study methodology. Infants will be randomised into either the control arm and receive current standard postoperative pain management or the intervention arm in which infants will receive postoperative pain management as per the model of NNCA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126662 0
Mrs Renee Muirhead
Address 126662 0
C/O Neonatal Critical Care Unit
Mater Mothers' Hospital,
Raymond Terrace
South Brisbane, QLD. 4101
Country 126662 0
Australia
Phone 126662 0
+61 0731635192
Fax 126662 0
Email 126662 0
renee.muirhead@mater.org.au
Contact person for public queries
Name 126663 0
Mrs Renee Muirhead
Address 126663 0
C/O Neonatal Critical Care Unit
Mater Mothers' Hospital,
Raymond Terrace
South Brisbane, QLD. 4101
Country 126663 0
Australia
Phone 126663 0
+61 07 31635192
Fax 126663 0
Email 126663 0
renee.muirhead@mater.org.au
Contact person for scientific queries
Name 126664 0
Mrs Renee Muirhead
Address 126664 0
C/O Neonatal Critical Care Unit
Mater Mothers' Hospital,
Raymond Terrace
South Brisbane, QLD. 4101
Country 126664 0
Australia
Phone 126664 0
+61 07 31635192
Fax 126664 0
Email 126664 0
renee.muirhead@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19173Study protocol  renee.muirhead@mater.org.au 385901-(Uploaded-11-06-2023-16-30-47)-Study-related document.docx
19174Ethical approval  renee.muirhead@mater.org.au 385901-(Uploaded-16-05-2023-14-04-41)-Study-related document.pdf
19179Ethical approval  renee.muirhead@mater.org.au 385901-(Uploaded-16-05-2023-14-09-33)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.