Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:
NCT ID: NCT02760888
Last Updated: 2016-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
102 participants
INTERVENTIONAL
2016-05-31
2016-07-31
Brief Summary
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Detailed Description
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Patients fulfilling inclusion and exclusion criteria will be divided into three groups.
Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.
Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.
Group C (control group) Include 34 patients who will receive a placebo.
Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Tramadol
Women will receive oral tramadol 100 mg 1 hour before the procedure
Tramadol
Women will receive a oral Tramadol 100mg 1 hour before the procedure
Diclofenac
Women will receive 100 mg diclofenac 1 hour before the procedure
Diclofenac
Women will receive oral Diclofenac 100mg 1 hour before the procedure
Placebo
Women will receive a placebo 1 hour before the procedure
Placebo
Women will receive a Placebo 1 hour before the procedure
Interventions
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Tramadol
Women will receive a oral Tramadol 100mg 1 hour before the procedure
Diclofenac
Women will receive oral Diclofenac 100mg 1 hour before the procedure
Placebo
Women will receive a Placebo 1 hour before the procedure
Eligibility Criteria
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Inclusion Criteria
* Scheduled for diagnostic hysteroscopy only.
* All of them should have given informed written consent.
Exclusion Criteria
* Receiving any other form of analgesia.
* Patients with known cervical stenosis, polyps and ulcers.
* Previous cervical surgery.
* Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy.
* known sensitivity to non-steroidal anti-inflammatory and opioids drugs.
* Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction.
* Unwilling to comply with the protocol, and Participation in another clinical trial in the last three months prior to the start of this study
18 Years
35 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Ahmed Elsayed Hassan Elbohoty
Assistant professor of Obstetrics and Gynecology Faculty of Medicine Ain Shams University
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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EDCU HY
Identifier Type: -
Identifier Source: org_study_id
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