Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy

NCT ID: NCT03532841

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2018-08-30

Brief Summary

The study objective is to evaluate the effectiveness of oral tramadol 50 mg in reducing pain during the colposcopy-directed cervical biopsy.half of the patients will receive oral tramadol tablets and the other half will receive a placebo.

Detailed Description

.Colposcopy-directed cervical biopsy (CDB) is a procedure performed in women with abnormal Papanicolaou smear or abnormal human papillomavirus (HPV) testing whose cervical lesions are colposcopically identified. Generally, no anaesthesia is needed for the procedure which can be done on an outpatient basis.The degree of pain associated with this procedure varies from mild to severe and many studies suggested that pain levels are often high reaching a score of more than 40 points on a 100-point visual analogue scale (VAS). Tramadol hydrochloride is an orally active centrally acting synthetic opioid. It is an atypical analgesic with a dual mechanism of action: serotonin and norepinephrine reuptake inhibition and modest l-opioid agonist. It has a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents

Conditions

Cervical Biopsy

Study Design

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

Study Groups

Group I (tramadol group)

Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.

Group Type: EXPERIMENTAL

an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet

Intervention Type: DRUG

Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.

Group II (placebo oral tablet group)

group II will receive a placebo one hour before the procedure.the Treatment and placebo will be identical in form and packaging, without any identifying label.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

placebo tablet of the same shape,color and taste will be given in the placebo arm

Interventions

an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet

Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.

Intervention Type: DRUG

Placebo Oral Tablet

placebo tablet of the same shape,color and taste will be given in the placebo arm

Intervention Type: DRUG

Other Intervention Names

placebo comparator or group II

Eligibility Criteria

Inclusion Criteria

Women with abnormal cervical cytology candidate for colposcopy and colposcopically directed biopsy or loop electrosurgical excision procedure.

Exclusion Criteria

• Patients taking psychotropic or anticoagulant medications or with histories of bleeding disorders or bleeding ulcers.
• Cervical and vaginal infection
• pregnant patients.
• Patients who had taken analgesics in the previous 24 hours, had a history of drug abuse or allergy to tramadol or opioids
• Patients with contraindications to tramadol as severe asthma, severe renal or hepatic impairment, People with uncontrolled epilepsy.
• People under the influence of (intoxicated with) alcohol, sleeping tablets, tranquilisers, psychotropic drugs (those affecting mood or emotions) or other opioid painkillers, e.g. morphine, codeine.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

lecturer in obstetrics and gynecology,faculty of medicine,Cairo university.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

AHMED SAMY, MD

Role: CONTACT

ahmedsamy8233@gmail.com

00201100681167

Other Identifiers

tramadol and colposcopy

Identifier Type: -

Identifier Source: org_study_id