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Trial record 82 of 450 for:    TRAMADOL

Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

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ClinicalTrials.gov Identifier: NCT02736019
Recruitment Status : Unknown
Verified July 2016 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:

Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique 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 and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).


Condition or disease Intervention/treatment Phase
Hysteroscopy Drug: Celecoxib Drug: Tramadol Drug: Placebo 1 Drug: Placebo 2 Phase 3

  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 for Reducing Pain During Office Hysteroscopy in Post Menopausal Women: A Double Blind Randomized Controlled Trial
Study Start Date : June 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Celecoxib
Women will receive oral celecoxib 200mg 2 hours before the procedure
Drug: Celecoxib
Women will receive oral Celecoxib 200mg 2 hours before the procedure

Drug: Placebo 1
Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.

Active Comparator: Tramadol
Women will receive oral Tramadol 100mg 2 hours before the procedure
Drug: Tramadol
Women will receive oral Tramadol 100 mg 2 hours before the procedure

Drug: Placebo 2
Women will receive an oral placebo similar to celecoxib 2 hours before the procedure

Placebo Comparator: Placebo
Women will receive a placebo similar to celecoxib and a placebo similar to Tramadol
Drug: Placebo 1
Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.

Drug: Placebo 2
Women will receive an oral placebo similar to celecoxib 2 hours before the procedure




Primary Outcome Measures :
  1. Patient's perception of pain during the procedure [ Time Frame: 2 minutes after starting the procedure ]
    The nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain.


Secondary Outcome Measures :
  1. Pain after the procedure [ Time Frame: 30 minutes after completing the procedure ]
    The nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post menopausal women.
  • vaginal bleeding.
  • Endometrial thickness >4mm.

Exclusion Criteria:

  • Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal , liver disease.
  • Gastritis or peptic ulcer.
  • Allergy to Tramadol or Celecoxib.

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): NCT02736019


Contacts
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Contact: AbdelGany M Hassan, MRCOG, MD +201017801604 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: Amr Wahba, MRCOG, MD         
Sub-Investigator: Hisham M Haggag, 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: NCT02736019     History of Changes
Other Study ID Numbers: Hyst 7
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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