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.
.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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
250
Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.
placebo tablet of the same shape,color and taste will be given in the placebo arm
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.
Time frame: immediately after speculum placement (baseline pain score).
patient-described pain level
the visual analogue scale score from 0-10
Time frame: 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.
Time frame: the overall pain at 30 min after the procedure (postprocedure pain score)
duration of colposcopy procedure.
relationship between pain score and colposcopy duration in minutes.
Time frame: from speculum insertion to colposcopy removal at the end of procedure.
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