Oral or rectal, diclofenac or paracetamol for the relief of perineal pain after childbirth: a randomised controlled trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000555257
• Date of registration: 08/07/2009
• Prospective Registration: No
• Primary sponsor: Northern Sydney & Central Coast Health, Human Research Ethics Committee
• 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.
• Date of first enrolment: 01/07/2004
• Target sample size: 240
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12609000555257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Donna Hartz

• Name: Donna Hartz

Key inclusion & exclusion criteria

Inclusion criteria: Primiparous women who have a second-degree tear or greater or an episiotomy after a vaginal birth.
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

Age minimum: 18 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Childbirth and postnatal care

Perineal pain;Pain Management;
Perineal pain
Pain Management

Intervention(s)

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

Primary Outcome(s)

Pain scores utilising the Short-form McGill Pian Questionnaire[24hours, 48 hours and 6 weeks post commencement of treatment]

Secondary Outcome(s)

Maternal satisfaction with birth experience
utilising a Visual Analogue scale, 0= not satisfied at all to 10 = extremely satisfied[24 hours, 48 hours and 6 weeks post birth]

Additional analgesia for pain recorded on patient medication chart and participant reported with tick box[24 hours and 48 hours post birth]

Blood Pressure measured by clinician using a sphygmomanometer[1hour, 4 hours and 24 hours post birth]

Recommendation of medication utilising a Visual Analogue scale, 0= no not at all to 10 = yes absolutely[24 hours, 48 hours, 6 weeks birth]

Length of Hospital stay as recorded in medical records.[At discharge]

Side effects: nausea, indigestion, vomiting, stomach pains, diarrhoea, constipation, difficulty passing urine - all participant reported with tick box[24 hours, 48 hours, 6 weeks post birth]

Breastfeeding rates, participant reported with tick box for breastfeeding with help, breastfeeding without help or not breastfeeding[24 hours, 48 hours and 6 weeks post birth]

Satisfaction with medication utilising a Visual Analogue scale, 0= not satisfied at all to 10 = extremely satisfied[24 hours, 48 hours, 6 weeks post birth]

Postnatal depression score using the Edinburgh Postnatal Depression Score[6 weeks post birth]

Use of ice packs participant reported with tick box[24 hours and 48 hours post birth]

Source(s) of Monetary Support

Northern Sydney & Cental Coast Health, Research Grants Committtee

Secondary Sponsor(s)

Northern Clinical School

Ethics review

Status: Approved
Approval date:
Contact:

Northern Sydney & Central Coast Health, Human Research Ethics Committee