Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: (OPH)
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|ClinicalTrials.gov Identifier: NCT02760888|
Recruitment Status : Unknown
Verified December 2015 by Ahmed Elsayed Hassan Elbohoty, Ain Shams University.
Recruitment status was: Not yet recruiting
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain, Procedure||Drug: Tramadol Drug: Diclofenac Drug: Placebo||Phase 3|
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite [ECDU].
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
Active Comparator: Tramadol
Women will receive oral tramadol 100 mg 1 hour before the procedure
Women will receive a oral Tramadol 100mg 1 hour before the procedure
Active Comparator: Diclofenac
Women will receive 100 mg diclofenac 1 hour before the procedure
Women will receive oral Diclofenac 100mg 1 hour before the procedure
Placebo Comparator: Placebo
Women will receive a placebo 1 hour before the procedure
Women will receive a Placebo 1 hour before the procedure
- Pain during the procedure [ Time Frame: intraoperative ]Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy
- pain after the procedure [ Time Frame: 15 minutes after completing the procedure ]15 minutes after procedure using a 100mm line visual analog scale
- Adverse effect and difficulties [ Time Frame: 24 hours ]Recorded in Case Record Form
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): NCT02760888
|Contact: Ahmed Elsayed Elbohoty, MDfirstname.lastname@example.org|
|Ain Shams University|