Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

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

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

Study Overview

• Status: Unknown
• Conditions: Perineal Pain
• Intervention / Treatment: Drug: Tramadol Hydrochloride; Drug: Celecoxib 200mg

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: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tramadol; one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.	Drug: Tramadol Hydrochloride; 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.	Drug: Celecoxib 200mg; Celecoxib 200 mg (Celebrex® 200, Pfizer,USA) administered orally immediately, 12 h and 24 h after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perineal pain	perineal pain severity using visual analogue scale	1 hour after repair of episiotomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perineal pain	perineal pain severity using visual analogue scale	1 hours after repair of episiotomy

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 10, 2018
• Primary Completion (ANTICIPATED): December 5, 2018
• Study Completion (ANTICIPATED): December 10, 2018

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (ACTUAL): October 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Cyclooxygenase 2 Inhibitors; Celecoxib; Tramadol
• Other Study ID Numbers: perineal pain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No