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

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Tramadol

• Registration Number: NCT02068209
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Study Start: 2014-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-03
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Patients referred for outpatient hysteroscopy
• Consent to the procedure

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive a placebo 1 hour before the procedure.
Tramadol	Tramadol	Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy

Primary Outcome Measures

Name	Time	Method
Pain perceived by the patient during the procedure	10 minutes after starting the procedure.	Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.

Secondary Outcome Measures

Name	Time	Method
Pain perceived by the patient 30 minutes after the procedure.	30 minutes after the procedure.	The level of pain will be assessed 30 minutes after the procedure by a visual analogue scale.

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt