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Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia

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ClinicalTrials.gov Identifier: NCT03694873
Recruitment Status : Not yet recruiting
First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

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

Condition or disease Intervention/treatment Phase
Perineal Pain Drug: Tramadol Hydrochloride Drug: Celecoxib 200mg Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Oral Tramadol Versus Oral Celecoxib for Post-perineal Repair Analgesia After Spontaneous Vaginal Birth in Obese Women: A Randomised Controlled Trial
Estimated Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 5, 2018
Estimated Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. perineal pain [ Time Frame: 1 hour after repair of episiotomy ]
    perineal pain severity using visual analogue scale


Secondary Outcome Measures :
  1. perineal pain [ Time Frame: 1 hours after repair of episiotomy ]
    perineal pain severity using visual analogue scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694873


Contacts
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Contact: AHMED SAMY, MD 01100681167 ahmedsamy8233@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AHMED SAMY, MD Cairo University

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Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03694873     History of Changes
Other Study ID Numbers: perineal pain
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celecoxib
Tramadol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants