Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Perineal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03694873
• Other study ID #: perineal pain
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 10, 2018
• Est. completion date: December 10, 2018

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: AHMED SAMY, MD
• Phone: 01100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 10, 2018
• Est. primary completion date: December 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perineal Pain

Intervention

Drug:
• Tramadol Hydrochloride
one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.
• Celecoxib 200mg
Celecoxib 200 mg (Celebrex® 200, P?zer,USA) administered orally immediately, 12 h and 24 h after randomization.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	perineal pain	perineal pain severity using visual analogue scale	1 hour after repair of episiotomy
Secondary	perineal pain	perineal pain severity using visual analogue scale	1 hours after repair of episiotomy