Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Phase 4

• Conditions: Perineal Pain
• Interventions: Drug: Celecoxib 200mg; Drug: Tramadol Hydrochloride

• Registration Number: NCT03694873
• Lead Sponsor: Cairo University

Brief Summary

This trial will be performed to compare the effectiveness of oral tramadol versus oral celecoxib for the management of perineal pain following episiotomy or perineal tear repair after spontaneous vaginal birth in obese women

Detailed Description

Pain after episiotomy or tear of perineal tissues during childbirth is often inadequately treated and may be severe. Not only did perineal pain negatively affect the physical and mental functioning of the woman, but also it might decrease the success of breastfeeding and reduced her ability to care for her child. The methods of relieving perineal pain included medication and non-medication. When the perineal pain was mild, the most common analgesic used was acetaminophen. Whereas the perineal pain was more severe, other drugs had been chosen such as opioid, non-opioid, and a combination of both opioid and non-opioid analgesics

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Last Update Submitted: 2018-10-02
• Study First Posted: 2018-10-03
• Last Update Posted: 2018-10-03
• Study Start: 2018-10-10
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Age:18-35 years
• Obese women with BMI ≥ 30.
• completed full 37-weeks gestation.
• spontaneous vaginal delivery with medio-lateral episiotomy or perineal tear requiring repair.
• Singleton alive fetus.

Exclusion Criteria

• known allergy to investigated drugs(tramadol or celecoxib).
• regular use of analgesic drugs before or during pregnancy.
• any medical condition known to be potentially exacerbated by opioids, including alimentary canal disorders, hepatic and renal disease.
• instrumental vaginal delivery.
• 3rd or 4th degree perineal tear.
• severe postpartum haemorrhage (>1,500 ml).
• complicating maternal diseases (pregestational/gestational diabetes mellitus; bleeding disorders; pre-eclampsia and other hypertensive disorders of pregnancy).
• epidural nor combined spinal-epidural analgesia in labour
• a history of peptic ulcer,asthma,thrombocytopaenia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
celecoxib	Celecoxib 200mg	one tablet of Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.
tramadol	Tramadol Hydrochloride	one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.

Primary Outcome Measures

Name	Time	Method
perineal pain	1 hour after repair of episiotomy	perineal pain severity using visual analogue scale

Secondary Outcome Measures

Name	Time	Method
perineal pain	1 hours after repair of episiotomy	perineal pain severity using visual analogue scale