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Trial record 79 of 451 for:    TRAMADOL

Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy

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ClinicalTrials.gov Identifier: NCT02736071
Recruitment Status : Unknown
Verified July 2016 by AbdelGany Hassan, Cairo University.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).


Condition or disease Intervention/treatment Phase
Hysteroscopy Drug: Celecoxib Drug: Tramadol Drug: Placebo 1 Drug: Placebo 2 Phase 3

Detailed Description:

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

All procedures will be scheduled to be done postmenstrual or after cessation of bleeding in case of metrorrhagia and will be done in the lithotomy position. The procedures will be performed using 30 degree angle 2.7 mm rigid hysteroscope with a 5mm outer diameter continuous flow hysteroscope with a 5 French working channel, a Teknolight 180 XA light source, and a Xenon high density fibre optic light cable 3.5mm, 2300mm Light cable without adaptors and a T Camera teknocam 2000S pro. All the equipment are provided by Tekno GmbH and Co®, Germany.

Vaginoscopic approach will be used for insertion of the hysteroscope in all cases. The hysteroscope will be gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. Patients will also be asked to report any side effects. The main outcome measure will be patients' pain perception during the procedure.

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.

Sample size calculation:

To the best of researchers knowledge this is the first trial to investigate the role of Celecoxib and oral Tramadol in reducing outpatient operative hysteroscopy associated pain, with no previous data to calculate the sample size with. Data from studies on diagnostic hysteroscopy cannot be applied because operative hysteroscopies need more manipulations and cause more pain. Assuming that the response will be normally distributed, the sample size is calculated to detect a mean difference of 1 unit between Tramadol and Celecoxib pain scores during the procedure (lower difference are not considered clinically relevant) using VAS assuming that the within group standard deviation will be 2. Investigators will need to study 64 cases in each group to be able to reject the null hypothesis that the population means of the Tramadol and Celecoxib are equal with probability (power) 0.8. Investigators added 6 cases to each arm accounting for any missing data and procedure failure ending in 70 cases in each group. The Type I error probability associated with this test of this null hypothesis is 0.05 using Student's t test for independent samples. Sample size calculation is done using Stats Direct statistical software version 2.7.2 for microsoft Windows, Stats Direct Ltd., Cheshire, UK.


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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: Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy: A Double Blind Placebo Controlled Trial.
Study Start Date : June 2016
Estimated Primary Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Celecoxib
Women will receive oral Celecoxib 200mg 2 hours before the procedure
Drug: Celecoxib
Women will receive oral Celecoxib 200mg 2 hours before the procedure

Active Comparator: Tramadol
Women will receive oral Tramadol 100 mg 2 hours before the procedure
Drug: Tramadol
Women will receive oral Tramadol 100mg 2 hours before the procedure

Placebo Comparator: Placebo
Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure
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 Celecoxib 2 hours before the procedure




Primary Outcome Measures :
  1. Pain perception during the procedure [ Time Frame: 5 minutes after starting the procedure ]
    A nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain


Secondary Outcome Measures :
  1. Pain perception after the procedure [ Time Frame: 30 minutes after completing the procedure ]
    A 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:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02736071


Contacts
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Contact: AbdelGany M Hassan, MRCOG, MD +201017801604 abdelgany2@gmail.com

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany MA Hassan, MRCOG, MD    00217801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sub-Investigator: Amr Wahba, MRCOG, MD         
Sub-Investigator: Hisham M Haggag, MD         
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AbdelGany M Hassan, MRCOG, MD Cairo University

Publications:
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02736071     History of Changes
Other Study ID Numbers: Hyst 8
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tramadol
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants