Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear

Phase 2

Completed

• Conditions: Perineal Tear; Perineal Laceration (Obstetric)
• Interventions: Drug: Diclofenac Sodium 50Mg Suppository; Drug: Paracetamol 500Mg Suppository

• Registration Number: NCT03041779
• Lead Sponsor: Clinical Research Centre, Malaysia

Brief Summary

To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.

Detailed Description

Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. Therefore, In view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Study First Submitted: 2016-12-12
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-01
• Last Update Submitted: 2017-02-01
• Study First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 909

Inclusion Criteria

Stage 1:

a) All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery

Stage 2:

1. All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June 2016.
2. All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery.
3. All pregnant women who have consented to involve in the study.

Exclusion Criteria

Stage 1:

1. Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth.
2. Patient who developed post-partum complications.

Stage 2:

1. Patient who is allergic to paracetamol or voltaren.
2. Patient who is unable to or unwilling to give consent.
3. Patient who is ended up with caesarean section.
4. Patient who sustained additional perineal tear including labial tear or periurethral tear.
5. Patient who developed postpartum complications (eg. Retained placenta, uterine atony, postpartum haemorrhage, multiple vaginal wall tear etc. )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paracetamol	Diclofenac Sodium 50Mg Suppository	Paracetamol 500Mg Suppository
Voltaren	Paracetamol 500Mg Suppository	Diclofenac Sodium 50Mg Suppository

Primary Outcome Measures

Name	Time	Method
perineum pain score following childbirth	at 2nd to 3rd hour post repair

Secondary Outcome Measures

Name	Time	Method
perineum pain score following childbirth	prior to discharge