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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03694873

Enrollment

200

Registered

2018-10-03

Start date

2018-10-10

Completion date

2018-12-10

Last updated

2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Pain

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

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

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

* 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.

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactAHMED SAMY, MD

ahmedsamy8233@gmail.com01100681167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026