Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Perineal Pain

Treatments: Drug: Tramadol Hydrochloride; Drug: Celecoxib 200mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03694873

perineal pain

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

tramadol

Experimental group

Description:

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

Treatment:

Drug: Tramadol Hydrochloride

celecoxib

Active Comparator group

Description:

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

Treatment:

Drug: Celecoxib 200mg