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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068209
• Other study ID #: Gany-123
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2014
• Last updated: April 3, 2015
• Start date: May 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred for outpatient hysteroscopy

• Consent to the procedure

Exclusion Criteria:

• Premenstrual patients

• Known cardiac disease

• Known allergy to Tramadol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Tramadol
patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.
• Placebo
patients will receive a placebo 1 hour before outpatient hysteroscopy

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Floris S, Piras B, Orrù M, Silvetti E, Tusconi A, Melis F, Tuveri M, Piga M, Paoletti AM, Melis GB. Efficacy of intravenous tramadol treatment for reducing pain during office diagnostic hysteroscopy. Fertil Steril. 2007 Jan;87(1):147-51. Epub 2006 Nov 1. — View Citation

Modi H, Mazumdar B, Bhatt J. Study of interaction of tramadol with amlodipine in mice. Indian J Pharmacol. 2013 Jan-Feb;45(1):76-9. doi: 10.4103/0253-7613.106440. — View Citation

O'Flynn H, Murphy LL, Ahmad G, Watson AJ. Pain relief in outpatient hysteroscopy: a survey of current UK clinical practice. Eur J Obstet Gynecol Reprod Biol. 2011 Jan;154(1):9-15. doi: 10.1016/j.ejogrb.2010.08.015. Review. — View Citation

Sharma JB, Aruna J, Kumar P, Roy KK, Malhotra N, Kumar S. Comparison of efficacy of oral drotaverine plus mefenamic acid with paracervical block and with intravenous sedation for pain relief during hysteroscopy and endometrial biopsy. Indian J Med Sci. 2009 Jun;63(6):244-52. doi: 10.4103/0019-5359.53394. — View Citation

van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain perceived by the patient during the procedure	Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.	10 minutes after starting the procedure.	No
Secondary	Pain perceived by the patient 30 minutes after the procedure.	The level of pain will be assessed 30 minutes after the procedure by a visual analogue scale.	30 minutes after the procedure.	No