Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001033639
Ethics application status
Approved
Date submitted
19/07/2023
Date registered
22/09/2023
Date last updated
22/09/2023
Date data sharing statement initially provided
22/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating use of inhaled dexmedetomidine for pain management in adult burn injury dressing changes
Scientific title
Evaluating whether nebulized dexmedetomidine can be used for pain management in adult burn injury dressing changes: A phase III pilot feasibility, randomized controlled crossover trial.
Secondary ID [1] 310017 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The IDEAS-B Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management in Burn injury patients 330522 0
Condition category
Condition code
Anaesthesiology 327375 327375 0 0
Pain management
Injuries and Accidents 327875 327875 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot phase III randomised controlled crossover trial to evaluate the feasibility and safety of conducting a large randomized controlled trial to provide effective analgesia using nebulized dexmedetomidine as an adjunct to conventional therapy for procedural pain management in burns patients. In addition, to capture pilot data to inform estimates of analgesic effect associated with nebulized dexmedetomidine when added to the conventional therapy used for procedural pain management in burns patients.

The drug, Dexmedetomidine, will be used for its registered purpose, sedation and analgesia, however this study will be investigating the use of an alternative method of administration (nebulisation) and will be compared with a placebo (0.9 % sodium chloride).

In this study 20 patients who meet the inclusion criteria and none of the exclusion criteria will be recruited. Participants will be randomised to receive either nebulised Dexmedetomidine or Placebo (0.9% Sodium Chloride) on the first occasion followed by the alternate option on the second occasion. This is in addition to the routine analgesia and sedation prescribed by the treating clinician. There will be at least 24 hours between the first and second dressing occasion.

A vibrating mesh nebulizer with mouthpiece and exhalation filter will be used for this study.

Patients will inhale the nebulized drug through a mouthpiece and will be instructed in detail using a demonstration by the research assistant regarding the inhalation method through the nebulizer.



Intervention- Dexmedetomidine 1 µg/kg will be instilled in the nebulizer chamber to make up to 3 mL of volume. Nebulization will be continued till there is no visible mist. The nebulized dose will be administered over approximately 1o minutes within 30 minutes prior to the commencement of the dressing change.

Participants will be observed for adherence and acceptance of the nebulisation procedure using a 9-point Likert scale. And monitored for adverse events relating to the study intervention.

Monitoring fidelity: A monitoring plan has been established for this study, including a Data Safety Monitoring Board. Protocol adherence will be easily monitored as this is a single site study and the study team will be directly involved in each case. The study will be conducted in accordance with ethical principles consistent with the Declaration of Helsinki, and all relevant national and local guidelines on the ethical conduct of research. The research team will include experienced research coordinators, intensive care specialists as all with GCP training and they will have oversight of all study required activities and protocol adherence.

All data will be directly entered from the source into the electronic database. The data base has the capacity to run validity checks and logic queries to minimise errors. The study monitor will perform 100% source data verification (SDV) for the first patient recruited and 100% SDV on all patients for informed consent in accordance with the HREC approval, reportable adverse events as per protocol, clinical outcome or pain assessment, and protocol deviations.





Intervention code [1] 326438 0
Treatment: Drugs
Intervention code [2] 326439 0
Treatment: Devices
Comparator / control treatment
This is a cross-over randomised study assessing the effectiveness of nebulised dexmedetomidine in burns patients expected to receive at least two consecutive dressing changes. Each patient will be their own control as they will receive both the dexmedetomidine and placebo on separate occasions.

Control- 3 mL of 0.9% sodium chloride (normal saline) will be nebulized. Nebulization will be continued till there is no visible mist.
Control group
Placebo

Outcomes
Primary outcome [1] 335243 0
Efficacy of analgesia using nebulized dexmedetomidine as an adjunct to conventional therapy.

Assessed by patient adherence and acceptance of nebulization procedure.
9-point Likert scale at completion of each burns dressing. Both measures will be assessed as a composite primary outcome.
Timepoint [1] 335243 0
At completion of each burns dressing
Primary outcome [2] 335255 0
To evaluate the feasibility and safety of conducting a large randomized controlled trial to provide effective analgesia using nebulized dexmedetomidine as an adjunct to conventional therapy for procedural pain management in burns patients.

The following adverse events will be recorded and reported

• bronchospasm, - Chest Auscultation
• hypoxia (SpO2< 90%), - SpO2 measured using finger pulse oximeter
• hypotension defined as SBP<90 mm Hg, - Blood pressure monitor
• bradycardia defined as <60 bpm. - heart rate monitor

Data Safety Monitoring Board (DSMB) will identify any serious safety concerns during that emerge through regular monitoring of the study progress.
Timepoint [2] 335255 0
Adverse events will be monitored and recorded continuously throughout the study.

DSMB will meet after the 1st, 5th, 10th and 20th (final) participant during this study.
Secondary outcome [1] 423626 0

Pain will be evaluated using numeric pain rating scale (NPRS) which has a domain of 0 to 10 score with 0 corresponding to non-painful state and 10 corresponding to the highest conceivable pain.

Timepoint [1] 423626 0
NPRS will be obtained from the patient at time 0 (baseline pre-procedure), immediately prior to the commencement of the nebulized dexmedetomidine/placebo, then at 30 min from the completion of the nebulization and at the end of the dressing procedure.

Secondary outcome [2] 426642 0
The requirement for inhaled nitrous oxide (Entonox) in minutes.
Timepoint [2] 426642 0
The requirement for inhaled nitrous oxide (Entonox) in minutes during study period - calculated cumulative time in minutes at completion of dressing change. Measured by digital stopwatch.

Eligibility
Key inclusion criteria
The following 2 groups of patients will be screened for suitability in accordance with the inclusion and exclusion criteria:
1. Patients who are planned to receive conservative treatment (not requiring surgical debridement and grafting) with requirement for regular dressing changes or baths.
2. Patients who have had surgical debridement and grafting and who have had their initial staple removal (typically day 3 or 4 following surgery) with subsequent requirement for regular dressing changes or baths.


Inclusion criteria
• Burn injured patients requiring inpatient care in the Prof Stuart Pegg Adult Burns Unit who are expected to undergo at least two consecutive dressing changes of similar intensity. These dressing changes must not include initial staple removal which tends to be a much more painful and prolonged procedure.
• Age >/= 18 years
• Able to provide consent to participate in the study.
• Able to orally inhale nebulized medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. Temperature >38 degrees C
2. Burns of the face
3. Burns of the lower respiratory tract such that this may impact on drug pharmacokinetics.
4. Systolic blood pressure (SBP) <100 mm Hg
5. Heart rate <60 beats per minute (bpm)
6. Cardiac dysrhythmia
7. Renal failure on dialysis
8. Patients with tracheostomy
9. Allergy to dexmedetomidine
10. Significant mental health disorder or psychological distress

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)
Allocation concealed through the use of a computerised randomisation tool with results only available to unblinded study team members not involved with any assessment or data collection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using procedures like coin-tossing and dice-rolling on a computer generated tool
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Patients are their own control
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables will be assessed for normality and expressed as means ± SD or medians ± IQR, and categorical variables will be expressed as proportions. Descriptive statistics will be used for demographic values. The difference in continuous variables will be analyzed with paired t-tests or Wilcoxon tests, and categorical variables will be tested with the McNemar test for paired dichotomous variables, as appropriate. Test of significance will be represented by * p <0.05, ** p <0.01, *** p <0.0001. For NPRS, the minimal important difference will be a reduction of at least 2/10.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/09/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
28/01/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25040 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 40701 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 314187 0
Charities/Societies/Foundations
Name [1] 314187 0
Royal Brisbane and Women's Hospital and Royal Brisbane and Women's Hospital Foundation Burns Research Project Grant
Country [1] 314187 0
Australia
Primary sponsor type
Hospital
Name
Metro North Health
Address
Level 7, Block 7 Royal Brisbane and Women’s Hospital corner of Butterfield and Herston Road, Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 316115 0
None
Name [1] 316115 0
Address [1] 316115 0
Country [1] 316115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313798 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 313798 0
Metro North Office of Research Level 7, Block 7, Royal Brisbane and Women's Hospital Campus corner Butterfield Street and Herston Road, Herston Qld 4029
Ethics committee country [1] 313798 0
Australia
Date submitted for ethics approval [1] 313798 0
28/02/2023
Approval date [1] 313798 0
24/04/2023
Ethics approval number [1] 313798 0
REC/2023/MNHB/94679

Summary
Brief summary
Study Title: The IDEAS-B STUDY Evaluating whether nebulized dexmedetomidine can be used for pain management in burn injury dressing changes.: A phase III pilot feasibility, randomized controlled crossover trial.

This is a pilot phase III randomised controlled crossover trial that will be conducted in the burn’s unit at the Royal Brisbane and Women’s Hospital. The drug, Dexmedetomidine, will be used for its registered purpose, sedation and analgesia, however this study will be investigating the use of an alternative method of administration (nebulisation).

Patients suffering from burns undergo procedures (dressing changes, de-stapling and burns baths) associated with pain and discomfort requiring analgesia/sedation. Inadequate analgesia/sedation causes complications such as patient discomfort, distress, noncompliance, difficulty nursing, and prolonged procedural time, adversely affecting wound healing and increasing hospital length of stay. Therefore, optimal procedural analgesia/sedation is vital for these patients. Currently, in RBWH burns patients, analgesia/sedation is provided by oral oxycodone 10mg and sublingual lorazepam 1mg with breakthrough inhaled nitrous oxide, but this is associated with several adverse effects (nausea, vomiting, and dizziness), and suboptimal clinical effect.

Dexmedetomidine, a centrally acting Alpha 2 agonist with analgesic, anxiolytic and sedative properties commonly administered by intravenous route is also able to be administered via the inhaled route using a nebulizer. Due to its pleiotropic effects, intravenous dexmedetomidine is used as an analgo-sedative in clinical medicine. However, Intravenous dexmedetomidine is associated with side effects such as hypotension and bradycardia.

Nebulization is a viable and effective alternative mode of drug delivery for systemic effects including analgesic agents due to the extensive surface area and perfusion of the lungs. Moreover, nebulized dexmedetomidine has been reported to have been used safely and effectively in other conditions. Nebulized dexmedetomidine can potentially achieve therapeutic plasma concentrations with lower peak (minimising adverse effects) and larger area under the plasma concentration-time curve, achieving adequate analgesia for a longer duration which is ideal for burns procedures in non-mechanically ventilated patients. However, currently there is no data supporting the use of nebulized dexmedetomidine for analgesia-sedation in burns patients.

We plan to recruit 20 participants per for this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127702 0
A/Prof Jayesh Dhanani
Address 127702 0
Department of Intensive Care ServicesRoyal Brisbane and Women's HospitalHerston RdHERSTON Qld 4029
Country 127702 0
Australia
Phone 127702 0
+61 7 36468897
Fax 127702 0
Email 127702 0
jayesh.dhanani@health.qld.gov.au
Contact person for public queries
Name 127703 0
A/Prof Jayesh Dhanani
Address 127703 0
Department of Intensive Care ServicesRoyal Brisbane and Women's HospitalHerston RdHERSTON Qld 4029
Country 127703 0
Australia
Phone 127703 0
+61 7 36468897
Fax 127703 0
Email 127703 0
jayesh.dhanani@health.qld.gov.au
Contact person for scientific queries
Name 127704 0
A/Prof Jayesh Dhanani
Address 127704 0
Department of Intensive Care ServicesRoyal Brisbane and Women's HospitalHerston RdHERSTON Qld 4029
Country 127704 0
Australia
Phone 127704 0
+61 7 36468897
Fax 127704 0
Email 127704 0
jayesh.dhanani@health.qld.gov.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
19583Study protocol  jayesh.dhanani@health.qld.gov.au
19584Ethical approval  jayesh.dhanani@health.qld.gov.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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