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Trial registered on ANZCTR


Registration number
ACTRN12609000555257
Ethics application status
Approved
Date submitted
3/07/2009
Date registered
8/07/2009
Date last updated
8/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oral or rectal, diclofenac or paracetamol for the relief of perineal pain after childbirth: a randomised controlled trial.
Scientific title
A randomised controlled trial comparing pain scores for rectal Diclofenac with oral Diclofenac and oral or rectal Paracetamol in primiparous women after childbirth.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perineal pain 237148 0
Pain Management 237149 0
Condition category
Condition code
Reproductive Health and Childbirth 237475 237475 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Control Group, Group 1: Rectal diclofenac 100mg every 12 hours for 48 hours, Group 2: Rectal paracetamol 1g every 6 hours for 48 hours, Group 3: Oral diclofenac 50mg every 8 hours for 48 hours, Group 4: Oral paracetamol 1g every 6 hours for 48 hours
Intervention code [1] 236863 0
Treatment: Drugs
Comparator / control treatment
1. Rectal diclofenac; 100mg every 12 hours for 48 hours
Control group
Active

Outcomes
Primary outcome [1] 238276 0
Pain scores utilising the Short-form McGill Pian Questionnaire
Timepoint [1] 238276 0
24hours, 48 hours and 6 weeks post commencement of treatment
Secondary outcome [1] 244652 0
Satisfaction with medication utilising a Visual Analogue scale, 0= not satisfied at all to 10 = extremely satisfied
Timepoint [1] 244652 0
24 hours, 48 hours, 6 weeks post birth
Secondary outcome [2] 244675 0
Recommendation of medication utilising a Visual Analogue scale, 0= no not at all to 10 = yes absolutely
Timepoint [2] 244675 0
24 hours, 48 hours, 6 weeks birth
Secondary outcome [3] 244676 0
Side effects: nausea, indigestion, vomiting, stomach pains, diarrhoea, constipation, difficulty passing urine - all participant reported with tick box
Timepoint [3] 244676 0
24 hours, 48 hours, 6 weeks post birth
Secondary outcome [4] 244677 0
Additional analgesia for pain recorded on patient medication chart and participant reported with tick box
Timepoint [4] 244677 0
24 hours and 48 hours post birth
Secondary outcome [5] 244678 0
Use of ice packs participant reported with tick box
Timepoint [5] 244678 0
24 hours and 48 hours post birth
Secondary outcome [6] 244679 0
Length of Hospital stay as recorded in medical records.
Timepoint [6] 244679 0
At discharge
Secondary outcome [7] 244680 0
Blood Pressure measured by clinician using a sphygmomanometer
Timepoint [7] 244680 0
1hour, 4 hours and 24 hours post birth
Secondary outcome [8] 244681 0
Postnatal depression score using the Edinburgh Postnatal Depression Score
Timepoint [8] 244681 0
6 weeks post birth
Secondary outcome [9] 244682 0
Maternal satisfaction with birth experience
utilising a Visual Analogue scale, 0= not satisfied at all to 10 = extremely satisfied
Timepoint [9] 244682 0
24 hours, 48 hours and 6 weeks post birth
Secondary outcome [10] 244683 0
Breastfeeding rates, participant reported with tick box for breastfeeding with help, breastfeeding without help or not breastfeeding
Timepoint [10] 244683 0
24 hours, 48 hours and 6 weeks post birth

Eligibility
Key inclusion criteria
Primiparous women who have a second-degree tear or greater or an episiotomy after a vaginal birth.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindications to non-steroidal anti-inflammatory medications
History of gastrointestinal ulcer or bleeding
Significant renal or liver impairment
Preeclampsia and essential hypertension.
Asthma
Postpartum haemorrhage greater than 1000mL
Medical disorders associated with a disturbed coagulation profile, in particular immune thrombocytopenic purpura, disseminated intravascular coagulation
Women of non-English speaking background
Women taking anticoagulants, Lithium, Digoxin, Chloramphenicol or diuretics

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)
Eligible primiparous women received written information about the trial from 36 weeks onwards. Women provided informed written consent prior to birth but were randomized only following birth and assessment of the perineum. Randomisation was to one of four groups. Medications were packaged by the clinical trial pharmacist and allocated a study number based on the randomisation schedule. Each treatment pack contained forty-eight hours of the designated analgesia that was not concealed. The randomised medication was commenced immediately following perineal repair.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule was prepared using a computer generated permutated randomisation block
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237261 0
Hospital
Name [1] 237261 0
Northern Sydney & Cental Coast Health, Research Grants Committtee
Address [1] 237261 0
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Country [1] 237261 0
Australia
Primary sponsor type
Hospital
Name
Northern Sydney & Central Coast Health, Human Research Ethics Committee
Address
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 236747 0
University
Name [1] 236747 0
Northern Clinical School
Address [1] 236747 0
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Country [1] 236747 0
Australia
Other collaborator category [1] 742 0
University
Name [1] 742 0
Centre for Women's health Nursing and Midwfiery
Address [1] 742 0
Level 1 Royal Hospital for Women
Randwick NSW 2031
Country [1] 742 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239363 0
Northern Sydney & Central Coast Health, Human Research Ethics Committee
Ethics committee address [1] 239363 0
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 239363 0
Australia
Date submitted for ethics approval [1] 239363 0
01/02/2004
Approval date [1] 239363 0
15/03/2004
Ethics approval number [1] 239363 0
0401-028M

Summary
Brief summary
This study provides evidence of the effectiveness of both the most commonly used analgesics (Diclofenac and Panadol), and the mode of administration (oral or rectal), in relieving perineal pain after childbirth. We hypothesised that:
1. Regular oral analgesia is equally as effective as rectal analgesia in relieving perineal pain after childbirth. 2. Diclofenac is more effective an analgesia than Panadol. 3. Women prefer oral analgesia to rectal analgesia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29838 0
Address 29838 0
Country 29838 0
Phone 29838 0
Fax 29838 0
Email 29838 0
Contact person for public queries
Name 13085 0
Donna Hartz
Address 13085 0
Centre for Women's Health Nursing and Midwifery & the University of Sydney
Level 1 Royal Hospital for Women
Randwick NSW2031
Country 13085 0
Australia
Phone 13085 0
+61292836737
Fax 13085 0
Email 13085 0
DHartz@usyd.edu.au
Contact person for scientific queries
Name 4013 0
Donna Hartz
Address 4013 0
Centre for Women's Health Nursing and Midwifery & the University of Sydney
Level 1 Royal Hospital for Women
Randwick NSW2031
Country 4013 0
Australia
Phone 4013 0
+61292836737
Fax 4013 0
Email 4013 0
DHartz@usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary