Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy

Tramadol Versus Diclofenac for Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo-Controlled Trial

The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during outpatient hysteroscopy. Women undergoing outpatient hysteroscopy in Cairo university will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale

Study Overview

• Status: Unknown
• Conditions: Pain, Procedural; Pain, Post Procedural
• Intervention / Treatment: Drug: Tramadol; Drug: Diclofenac; Drug: Placebo

Detailed Description

Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.

Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.

Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.

Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.

The study will be conducted in the outpatient 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 oral consent. Written informed consent is not needed since the procedure and intervention carries almost no risk to the patient and the patient will not receive anesthesia and will be fully conscious. Only patients consenting verbally to participate will be included in the trial.

Tramadol, diclofenac and placebo will be enclosed in sealed envelopes which will be numbered using computer generated random table. Neither the patient nor the physician will be aware of the drug used. 210 women will be categorized into 3 groups: Group I who will receive Tramadol 100mg (Trama SR®, Global Napi) orally 1 hour before the procedure, group II who will receive diclofenac 100mg (voltaren® 100, Novartis) 1 hour before the procedure, and group III who will receive 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 and perception of pain will be compared.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Indication to do outpatient hysteroscopy
• Consents to the procedure
• Postmenstrual

Exclusion Criteria:

• Known allergy to tramadol or diclofenac
• Cardiac renal or gastric disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Tramadol; Women will receive oral Tramadol 100 mg before the procedure	Drug: Tramadol; Women will receive oral tramadol 100 mg 1 hour before the procedure
ACTIVE_COMPARATOR: Diclofenac; Women will receive oral diclofenac 100 mg before the procedure	Drug: Diclofenac; Women will receive 100 mg diclofenac 1 hour before the procedure
PLACEBO_COMPARATOR: Placebo; Women will receive oral placebo 1 hour before the procedure.	Drug: Placebo; Women will receive a placebo 1 hour before the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during the procedure	Women will be asked to score their pain using a visual analogue scale	5 minutes after starting the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after the procedure	Women will be asked to score their pain using a visual analogue scale	30 minutes after competing the procedure

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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. doi: 10.1111/j.1471-0528.2007.01326.x.
• Ahmad G, Attarbashi S, O'Flynn H, Watson AJ. Pain relief in office gynaecology: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2011 Mar;155(1):3-13. doi: 10.1016/j.ejogrb.2010.11.018. Epub 2011 Jan 20.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (ESTIMATE): April 17, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): January 23, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: out patient hysteroscopy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Diclofenac; Tramadol
• Other Study ID Numbers: Hyst 3