Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

NCT ID: NCT03694873

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2018-12-10

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

Conditions

Perineal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tramadol

one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.

Group Type: EXPERIMENTAL

Tramadol Hydrochloride

Intervention Type: DRUG

one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.

celecoxib

one tablet of Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.

Group Type: ACTIVE_COMPARATOR

Celecoxib 200mg

Intervention Type: DRUG

Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.

Interventions

Tramadol Hydrochloride

one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.

Intervention Type: DRUG

Celecoxib 200mg

Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

lecturer in obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

AHMED SAMY, MD

Role: CONTACT

ahmedsamy8233@gmail.com

01100681167

Other Identifiers

perineal pain

Identifier Type: -

Identifier Source: org_study_id