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

NCT03532841 | Unknown

• 1 other identifier: tramadol and colposcopy
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Biopsy

Outcome Measures

Primary Outcomes (3)

• patient-described pain level

  the mean patient-described pain level will be measured with the visual analogue scale (VAS). Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. Subjects will be told that the far left point will represent "no pain "and the far right point will represent "the worst pain you can imagine." They will be asked to mark a vertical line on the visual analogue scale during the procedure to note levels of discomfort.

  immediately after speculum placement (baseline pain score).

• patient-described pain level

  the visual analogue scale score from 0-10

  after the first ectocervical biopsy(approximately 5 minutes after speculum insertion)

• patient-described pain level

  (postprocedure pain score) using the visual analogue scale score from 0-10.

  the overall pain at 30 min after the procedure (postprocedure pain score)

Secondary Outcomes (1)

• duration of colposcopy procedure.

  from speculum insertion to colposcopy removal at the end of procedure.

Study Arms (2)

Group I (tramadol group)

EXPERIMENTAL

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

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

Group II (placebo oral tablet group)

PLACEBO COMPARATOR

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.

Drug: Placebo Oral Tablet

Interventions

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

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

Group I (tramadol group)

Placebo Oral Tablet DRUG

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

Also known as: placebo comparator or group II

Group II (placebo oral tablet group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Tramadol; Tablets

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• AHMED SAMY, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED SAMY, MD

CONTACT

00201100681167; ahmedsamy8233@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in obstetrics and gynecology,faculty of medicine,Cairo university.

Model Details: A randomised double-blind placebo-controlled trial.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 22, 2018
• Study Start: May 15, 2018
• Primary Completion: August 20, 2018
• Study Completion: August 30, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05