CClinicalTrials.gg
Status unknownNCT03694873Updated Oct 3, 2018

Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

A Phase 4 interventional study of Tramadol Hydrochloride and Celecoxib 200mg in Perineal Pain, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-03.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Perineal Pain
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
200 participants (estimated)

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.

    Drug: Tramadol Hydrochloride

  • 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

Interventions

  • DrugTramadol Hydrochloride

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

  • DrugCelecoxib 200mg

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

06

What researchers measure

Primary outcomes

  1. perineal pain

    perineal pain severity using visual analogue scale

    Time frame: 1 hour after repair of episiotomy

Secondary outcomes

  1. perineal pain

    perineal pain severity using visual analogue scale

    Time frame: 1 hours after repair of episiotomy

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03694873
Lead sponsor
Cairo University
Responsible party
Ahmed Samy aly ashour (lecturer in obstetrics and gynecology, Cairo University) — Principal investigator
First posted
Oct 3, 2018
Start date
Oct 10, 2018 (estimated)
Primary completion
Dec 5, 2018 (estimated)
Completion
Dec 10, 2018 (estimated)
Last update
Oct 3, 2018

Study contacts

AHMED SAMY, MD
Contact
ahmedsamy8233@gmail.com
01100681167
AHMED SAMY, MD
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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