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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2016 |
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Main ID: |
NCT02736071 |
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Date of registration:
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08/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy
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Scientific title:
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Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy: A Double Blind Placebo Controlled Trial. |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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210 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02736071 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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AbdelGany MA Hassan, MRCOG, MD |
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Address:
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Telephone:
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00217801604 |
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Email:
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abdelgany2@gmail.com |
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Affiliation:
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Name:
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AbdelGany M Hassan, MRCOG, MD |
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Address:
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Telephone:
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+201017801604 |
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Email:
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abdelgany2@gmail.com |
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Affiliation:
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Name:
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AbdelGany M Hassan, MRCOG, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Indication for operative outpatient hysteroscopy, indications will include
endometrial biopsy, polypectomy, septum resection, intra-uterine device removal and
adhesiolysis.
Exclusion Criteria:
- Submucous myomas.
- Known medical disorders like uncontrolled diabetes, hypertension, cardiac, renal or
liver disease.
- Gastritis or peptic ulcer.
- Allergy to Tramadol or Celecoxib.
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hysteroscopy
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Intervention(s)
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Drug: Tramadol
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Drug: Celecoxib
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Drug: Placebo 2
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Drug: Placebo 1
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Primary Outcome(s)
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Pain perception during the procedure
[Time Frame: 5 minutes after starting the procedure]
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Secondary Outcome(s)
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Pain perception after the procedure
[Time Frame: 30 minutes after completing the procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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