Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ahmed Samy aly ashour，Cairo University

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 10, 2018

Estimated Primary Completion Date

December 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

perineal pain[ Time Frame: 1 hour after repair of episiotomy ]

perineal pain severity using visual analogue scale

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Official Title ^ICMJE

Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 10, 2018

Estimated Primary Completion Date

December 5, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ahmed Samy aly ashour，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: AHMED SAMY, MD Cairo University

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名