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Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03585036
Recruitment Status : Unknown
Verified June 2018 by Ahmed Samy aly ashour, Cairo University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date July 12, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy
Official Title  ICMJE Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Hysteroscopy
Intervention  ICMJE
  • 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.

  • 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

  • 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

Study Arms  ICMJE
  • 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.

    Intervention: Drug: dexketoprofen
  • 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

    .

    Intervention: Drug: Tramadol
  • 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

    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03585036
Other Study ID Numbers  ICMJE tramadol
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Samy aly ashour, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AHMED SAMY, MD lecturer in obstetrics and gynecology,cairo university
PRS Account Cairo University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP