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

Cervical Biopsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03532841
• Other study ID #: tramadol and colposcopy
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: August 30, 2018

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: AHMED SAMY, MD
• Phone: 00201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 30, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Biopsy

Intervention

Drug:
• an 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.
• Placebo Oral Tablet
placebo tablet of the same shape,color and taste will be given in the placebo arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	patient-described pain level	the visual analogue scale score from 0-10	after the ?rst ectocervical biopsy(approximately 5 minutes after speculum insertion)
Primary	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	duration of colposcopy procedure.	relationship between pain score and colposcopy duration in minutes.	from speculum insertion to colposcopy removal at the end of procedure.