Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

NCT03694873 | Unknown Phase 4

• 1 other identifier: perineal pain
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Perineal Pain

Outcome Measures

Primary Outcomes (1)

• perineal pain

  perineal pain severity using visual analogue scale

  1 hour after repair of episiotomy

Secondary Outcomes (1)

• perineal pain

  1 hours after repair of episiotomy

Study Arms (2)

tramadol

EXPERIMENTAL

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

Drug: Tramadol Hydrochloride

celecoxib

ACTIVE COMPARATOR

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

Drug: Celecoxib 200mg

Interventions

Tramadol Hydrochloride DRUG

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

tramadol

Celecoxib 200mg DRUG

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

celecoxib

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• rd 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Tramadol; Celecoxib

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

01100681167; ahmedsamy8233@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 3, 2018
• Study Start: October 10, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 10, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10