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

Cairo University (CU)

Status: Unknown

Conditions: Cervical Biopsy

Treatments: Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03532841

tramadol and colposcopy

Details and patient eligibility

About

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.

Full 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

Enrollment: 250 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Group I (tramadol group)

Experimental group

Description:

Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.

Treatment:

Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet

Group II (placebo oral tablet group)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet