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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03041779
Acronym
SuPPerP
Enrollment
909
Registered
2017-02-03
Start date
2015-10-31
Completion date
2016-07-31
Last updated
2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Laceration (Obstetric), Perineal Tear

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.

Interventions

DRUGDiclofenac Sodium 50Mg Suppository
DRUGParacetamol 500Mg Suppository

Sponsors

Clinical Research Centre, Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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. )

Design outcomes

Primary

MeasureTime frame
perineum pain score following childbirthat 2nd to 3rd hour post repair

Secondary

MeasureTime frame
perineum pain score following childbirthimmediate after delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026