Clinical trial NCT03532841: Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy
Official title: Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Biopsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised double-blind placebo-controlled trial.
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: patient-described pain level
timeFrame: immediately after speculum placement (baseline pain score).
measure: patient-described pain level
timeFrame: after the ﬁrst ectocervical biopsy(approximately 5 minutes after speculum insertion)
measure: patient-described pain level
timeFrame: the overall pain at 30 min after the procedure (postprocedure pain score)
Secondary outcomes:
measure: duration of colposcopy procedure.
timeFrame: from speculum insertion to colposcopy removal at the end of procedure.
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: