Cervical Biopsy
Conditions
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
Interventions
DRUGan 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.
DRUGPlacebo Oral Tablet
placebo tablet of the same shape,color and taste will be given in the placebo arm
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomised double-blind placebo-controlled trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient-described pain level | immediately after speculum placement (baseline pain score). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of colposcopy procedure. | from speculum insertion to colposcopy removal at the end of procedure. | relationship between pain score and colposcopy duration in minutes. |
Contacts
Primary ContactAHMED SAMY, MD
Outcome results
None listed