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Tramadol Versus Celecoxib in Reducing Pain Associated With IUD Insertion (IUD)

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ClinicalTrials.gov Identifier: NCT02827487
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:

Two hundred and ten women requesting IUD insertion will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure.

After insertion of the IUD the women's pain perception will be assessed using a visual analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10 corresponding to the worst possible pain.


Condition or disease Intervention/treatment Phase
Pain Drug: Tramadol Drug: Celecoxib Drug: Placebo 1 Drug: Placebo 2 Procedure: IUD Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tramadol Versus Celecoxib in Reducing Pain Associated With IUD Insertion: A Double Blind Placebo Controlled Trial
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tramadol
Women will receive oral Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) and an oral placebo similar to Celecoxib 2 hours before IUD insertion.
Drug: Tramadol
Women will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally 2 hours before IUD insertion.

Drug: Placebo 2
Women will receive a placebo similar to Celecoxib orally 2 hours before IUD insertion.

Procedure: IUD
IUD insertion

Active Comparator: Celecoxib
Women will receive oral Celecoxib 200mg (Celebrex® 200, Pfizer, USA) and an oral placebo similar to Tramadol 2 hours before IUD insertion.
Drug: Celecoxib
Women will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) orally 2 hours before IUD insertion.

Drug: Placebo 1
Women will receive a placebo similar to Tramadol orally 2 hours before IUD insertion.

Procedure: IUD
IUD insertion

Placebo Comparator: Placebo 1
Women will receive a placebo similar to Tramadol and a placebo similar to Celecoxib orally 2 hours before IUD insertion.
Drug: Placebo 1
Women will receive a placebo similar to Tramadol orally 2 hours before IUD insertion.

Drug: Placebo 2
Women will receive a placebo similar to Celecoxib orally 2 hours before IUD insertion.

Procedure: IUD
IUD insertion




Primary Outcome Measures :
  1. Pain after IUD insertion [ Time Frame: one minute after IUD insertion ]
    Women will mark a point corresponding to their pain on a visual analogue scale



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with expected difficult IUD insertion like nulliparous women and women with previous cesarean section.

Exclusion Criteria:

  • Previous vaginal delivery.
  • Submucous myoma.
  • Uterine anomalies.
  • Undiagnosed vaginal bleeding.
  • Pelvic inflammatory disease.

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): NCT02827487


Contacts
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Contact: AbdelGany M Hassan, MRCOG, MD 1017801604 abdelgany2@gmail.com

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sub-Investigator: Mohamed Kotb, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AbdelGany M Hassan Cairo University

Publications:
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02827487     History of Changes
Other Study ID Numbers: Celecoxib IUD
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Tramadol
Celecoxib
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