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

Not Applicable

• Conditions: Cervical Biopsy
• Interventions: Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet; Drug: Placebo Oral Tablet

• Registration Number: NCT03532841
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2018-04-13
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-10
• Last Update Submitted: 2018-05-10
• Study Start: 2018-05-15
• Study First Posted: 2018-05-22
• Last Update Posted: 2018-05-22
• Primary Completion: 2018-08-20
• Study Completion: 2018-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (tramadol group)	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.
Group II (placebo oral tablet group)	Placebo Oral Tablet	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.

Primary Outcome Measures

Name	Time	Method
patient-described pain level	the overall pain at 30 min after the procedure (postprocedure pain score)	(postprocedure pain score) using the visual analogue scale score from 0-10.

Secondary Outcome Measures

Name	Time	Method
duration of colposcopy procedure.	from speculum insertion to colposcopy removal at the end of procedure.	relationship between pain score and colposcopy duration in minutes.