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Trial record 62 of 451 for:    TRAMADOL

Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy

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ClinicalTrials.gov Identifier: NCT02428777
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:
The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale

Condition or disease Intervention/treatment Phase
Pain Drug: Tramadol Drug: Diclofenac Drug: Placebo Phase 3

Detailed Description:

Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.

Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.

Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.

Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.

The study will be conducted in the outpatient hysteroscopy clinic in Cairo university hospitals. All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide oral consent. Written informed consent is not needed since the procedure and Patients will be included in the study if they give written consents.

Tramadol, diclofenac and placebo will be enclosed in sealed envelopes which will be numbered using computer generated random table. Neither the patient nor the physician will be aware of the drug used. 210 women will be categorized into 3 groups: Group I who will receive oral Tramadol 100mg (Trama®, Global Napi) orally 1 hour before the procedure, group II who will receive oral diclofenac 100mg (voltaren® 100, Novartis) 1 hour before the procedure, and group III who will receive an oral placebo.

Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg.

The anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. Endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 5Charr provided by Tecchno medical GmbH. The used scissor will be a single action semi-rigid rounded tip scissors provided by Tecchno medical GmbH.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial
Study Start Date : April 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tramadol
Women will receive oral tramadol 100 mg 1 hour before the procedure
Drug: Tramadol
Women will receive oral tramadol 100 mg 1 hour before the procedure.

Active Comparator: Diclofenac
Women will receive oral diclofenac 100 mg 1 hour before the procedure
Drug: Diclofenac
Women will receive oral diclofenac 100 mg 1 hour before the procedure

Placebo Comparator: Placebo
Women will receive an oral placebo 1 hour before the procedure
Drug: Placebo
Women will receive an oral placebo 1 hour before the procedure




Primary Outcome Measures :
  1. Pain during the procedure as measured by the visual analogue scale [ Time Frame: 5 minutes after starting the procedure ]
    Women will be asked to score their pain using a visual analogue scale

  2. Pain after the procedure as measured by the visual analogue scale [ Time Frame: 30 minutes after completing the procedure ]
    Women will be asked to score their pain using a visual analogue scale



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for operative outpatient hysteroscopy like endometrial biopsy, endometrial polyp, uterine septum, intrauterine adhesions, and loop retrieval.

Exclusion Criteria:

  • Known allergy to tramadol or diclofenac.
  • Diabetes, hypertension, gastritis, peptic ulcer, cardiac, renal or liver disease.

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): NCT02428777


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

Locations
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Egypt
BeniSuef University hospitals Recruiting
BeniSuef, Egypt
Contact: Nesreen AA Shehata, MD    +2001227866337    nesoomar@yahoo.com   
Cairo university hospitals Recruiting
Cairo, Egypt
Contact: AbdelGany Hassan, MRCOG, MD    002 01017801604    abdelgany2@gmail.com   
Principal Investigator: AbdelGany MA Hassan, MRCOG, MD         
Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02428777     History of Changes
Other Study ID Numbers: Hyst 5
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Keywords provided by AbdelGany Hassan, Cairo University:
Hysteroscopy
Additional relevant MeSH terms:
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Tramadol
Diclofenac
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 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants