Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Overview

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

Full Title of Study: “Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 5, 2018

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

Interventions

  • Drug: Tramadol Hydrochloride
    • one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.
  • Drug: Celecoxib 200mg
    • Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.

Arms, Groups and Cohorts

  • Experimental: tramadol
    • one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.
  • Active Comparator: celecoxib
    • one tablet of Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.

Clinical Trial Outcome Measures

Primary Measures

  • perineal pain
    • Time Frame: 1 hour after repair of episiotomy
    • perineal pain severity using visual analogue scale

Secondary Measures

  • perineal pain
    • Time Frame: 1 hours after repair of episiotomy
    • perineal pain severity using visual analogue scale

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology – Cairo University
  • Overall Official(s)
    • AHMED SAMY, MD, Principal Investigator, Cairo University
  • Overall Contact(s)
    • AHMED SAMY, MD, 01100681167, ahmedsamy8233@gmail.com

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