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Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

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ClinicalTrials.gov Identifier: NCT03585036
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, 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 dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) 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.

Condition or disease Intervention/treatment Phase
Hysteroscopy Drug: dexketoprofen Drug: Tramadol Drug: Placebo Phase 3

Detailed Description:

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 dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) 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.

Statistics:

Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.


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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: Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: dexketoprofen

Drug: dexketoprofen Women will receive oral dexketoprofen 25mg 2 hours before the procedure

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

Drug: dexketoprofen

Drug: dexketoprofen Women will receive oral dexketoprofen 25mg 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

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 dexketoprofen 2 hours before the procedure

.

Drug: Tramadol

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 dexketoprofen 2 hours before the procedure


Placebo Comparator: placebo

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 dexketoprofen 2 hours before the procedure

Drug: Placebo

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 dexketoprofen 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.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced 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 dexketoprofen.

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): NCT03585036


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 lecturer in obstetrics and gynecology,cairo university

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Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT03585036     History of Changes
Other Study ID Numbers: tramadol
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 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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Tramadol
Dexketoprofen trometamol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents