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Trial record 16 of 471 for:    TRAMADOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE May 22, 2018
Last Update Posted Date May 22, 2018
Estimated Study Start Date  ICMJE May 15, 2018
Estimated Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • 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.
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy
Official Title  ICMJE Role of Oral Tramadol 50 mg in Reducing Pain During Colposcopy-directed Cervical Biopsy: A Randomised Double-blind Placebo-controlled Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Cervical Biopsy
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Experimental: Group I (tramadol group)
    Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.
    Intervention: Drug: an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet
  • 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.
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2018)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2018
Estimated Primary Completion Date August 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: AHMED SAMY, MD 00201100681167 ahmedsamy8233@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03532841
Other Study ID Numbers  ICMJE tramadol and colposcopy
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmed Samy aly ashour, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: AHMED SAMY, MD Cairo University
PRS Account Cairo University
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP