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Completed

NCT Number: NCT03041779

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

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Exclusion criteria

Stage 1:

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

Stage 2:

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

Treatment and study plan

Diclofenac Sodium 50Mg Suppository

Drug

Other names: Voltaren 50Mg Suppository

Paracetamol 500Mg Suppository

Drug

Other names: Acetaminophen 500Mg Suppository

Primary outcomes

  1. perineum pain score following childbirth

    Time frame: at 2nd to 3rd hour post repair

Secondary outcomes

  1. perineum pain score following childbirth

    Time frame: immediate after delivery

  2. perineum pain score following childbirth

    Time frame: immediate post perineum repair

  3. perineum pain score following childbirth

    Time frame: at 5th to 6th hour post repair

  4. perineum pain score following childbirth

    Time frame: prior to discharge

Sponsors and collaborators

Lead sponsor

Clinical Research Centre, Malaysia

Other

Registry information

Official study title

A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth

Acronym: SuPPerP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2017
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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