NCT03041779

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 909 (actual)
• Sponsor: Clinical Research Centre, Malaysia · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Perineal Tear
• Perineal Laceration (Obstetric)

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium 50Mg Suppository
DRUG	Paracetamol 500Mg Suppository

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2017-02-03
• Last updated: 2017-02-03