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

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ClinicalTrials.gov Identifier: NCT03532841
Recruitment Status : Not yet recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Samy aly ashour, Cairo University

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.

Condition or disease Intervention/treatment Phase
Cervical Biopsy Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet Drug: Placebo Oral Tablet Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomised double-blind placebo-controlled trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: Group I (tramadol group)
Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.
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 Comparator: Group II (placebo oral tablet group)
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.
Drug: Placebo Oral Tablet
placebo tablet of the same shape,color and taste will be given in the placebo arm
Other Name: placebo comparator or group II




Primary Outcome Measures :
  1. patient-described pain level [ Time Frame: 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.

  2. patient-described pain level [ Time Frame: after the first ectocervical biopsy(approximately 5 minutes after speculum insertion) ]
    the visual analogue scale score from 0-10

  3. patient-described pain level [ Time Frame: the overall pain at 30 min after the procedure (postprocedure pain score) ]
    (postprocedure pain score) using the visual analogue scale score from 0-10.


Secondary Outcome Measures :
  1. duration of colposcopy procedure. [ Time Frame: from speculum insertion to colposcopy removal at the end of procedure. ]
    relationship between pain score and colposcopy duration in minutes.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532841


Contacts
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Contact: AHMED SAMY, MD 00201100681167 ahmedsamy8233@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: AHMED SAMY, MD Cairo University

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Responsible Party: Ahmed Samy aly ashour, lecturer in obstetrics and gynecology,faculty of medicine,Cairo university., Cairo University
ClinicalTrials.gov Identifier: NCT03532841     History of Changes
Other Study ID Numbers: tramadol and colposcopy
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents