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Completed

NCT Number: NCT02068209

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University Hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients referred for outpatient hysteroscopy
  • Consent to the procedure

Exclusion criteria

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

Treatment and study plan

Tramadol

Drug

patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.

Other names: Tramadol 50mg

Placebo

Drug

patients will receive a placebo 1 hour before outpatient hysteroscopy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Role of Tramadol 50mg in Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 21, 2014
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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