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

Cairo University (CU)

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Tramadol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02068209

Gany-123

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for outpatient hysteroscopy
• Consent to the procedure

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Tramadol

Active Comparator group

Description:

Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy

Treatment:

Drug: Tramadol

Placebo

Placebo Comparator group

Description:

Patients will receive a placebo 1 hour before the procedure.

Treatment:

Drug: Placebo