Tramadol Versus Diclofenac for Reducing Pain Before Outpatient Hysteroscopy

NCT ID: NCT02419651

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-12-31

Brief Summary

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

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.

Conditions

Pain, Post Procedural; Pain, Procedural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tramadol

Women will receive oral Tramadol 100 mg before the procedure

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

Women will receive oral tramadol 100 mg 1 hour before the procedure

Diclofenac

Women will receive oral diclofenac 100 mg before the procedure

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Women will receive 100 mg diclofenac 1 hour before the procedure

Placebo

Women will receive oral placebo 1 hour before the procedure.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Women will receive a placebo 1 hour before the procedure

Interventions

Tramadol

Women will receive oral tramadol 100 mg 1 hour before the procedure

Intervention Type: DRUG

Diclofenac

Women will receive 100 mg diclofenac 1 hour before the procedure

Intervention Type: DRUG

Placebo

Women will receive a placebo 1 hour before the procedure

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

AbdelGany MA Hassan, MRCOG, MD

Role: primary

abdelgany2@gmail.com

00217801604

References

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.

Reference Type: BACKGROUND

PMID: 21255900 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17516956 (View on PubMed)

Other Identifiers

Hyst 3

Identifier Type: -

Identifier Source: org_study_id