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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

909 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perineal Tear Perineal Laceration (Obstetric)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Paracetamol

Paracetamol 500Mg Suppository

Group Type ACTIVE_COMPARATOR

Diclofenac Sodium 50Mg Suppository

Intervention Type DRUG

Voltaren

Diclofenac Sodium 50Mg Suppository

Group Type ACTIVE_COMPARATOR

Paracetamol 500Mg Suppository

Intervention Type DRUG

Interventions

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Diclofenac Sodium 50Mg Suppository

Intervention Type DRUG

Paracetamol 500Mg Suppository

Intervention Type DRUG

Other Intervention Names

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Voltaren 50Mg Suppository Acetaminophen 500Mg Suppository

Eligibility Criteria

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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. )

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No