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

Study Overview
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Brief Summary
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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
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.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

Official Title
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Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial

Conditions
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Cervical Biopsy

Intervention / Treatment
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* Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised double-blind placebo-controlled trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (tramadol group)<br>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<br>* Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.<br>|
| Placebo Comparator: Group II (placebo oral tablet group)<br>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<br>* placebo tablet of the same shape,color and taste will be given in the placebo arm<br>* Other names: placebo comparator or group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of colposcopy procedure. | relationship between pain score and colposcopy duration in minutes. | from speculum insertion to colposcopy removal at the end of procedure. |