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Evaluation of the Role of Tramadol 50mg as an Analgesic During Outpatient Hysteroscopy

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ClinicalTrials.gov Identifier: NCT02068209
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:
The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.

Condition or disease Intervention/treatment Phase
Pain Drug: Tramadol Drug: Placebo Phase 2

Detailed Description:

This study is a prospective double blinded randomised controlled trial. 140 women will be recruited from the office 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 written consents. Only patients consenting to participate will be included in the trial.

Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a placebo acting as the control group.

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 visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.

Base line characteristics will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Role of Tramadol 50mg in Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial.
Study Start Date : May 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: Tramadol
Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy
Drug: Tramadol
patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.
Other Name: Tramadol 50mg

Placebo Comparator: Placebo
Patients will receive a placebo 1 hour before the procedure.
Drug: Placebo
patients will receive a placebo 1 hour before outpatient hysteroscopy




Primary Outcome Measures :
  1. Pain perceived by the patient during the procedure [ Time Frame: 10 minutes after starting the procedure. ]
    Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.


Secondary Outcome Measures :
  1. Pain perceived by the patient 30 minutes after the procedure. [ Time Frame: 30 minutes after the procedure. ]
    The level of pain will be assessed 30 minutes after the procedure by a visual analogue scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred for outpatient hysteroscopy
  • Consent to the procedure

Exclusion Criteria:

  • Premenstrual patients
  • Known cardiac disease
  • Known allergy to Tramadol

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): NCT02068209


Locations
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Egypt
Cairo University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AbdelGany MA Hassan, MRCOG, MD Cairo University

Publications:
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Responsible Party: AbdelGany Hassan, Dr Hassan, Cairo University
ClinicalTrials.gov Identifier: NCT02068209     History of Changes
Other Study ID Numbers: Gany-123
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by AbdelGany Hassan, Cairo University:
Outpatient hysteroscopy
Tramadol

Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents