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Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: (OPH)

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ClinicalTrials.gov Identifier: NCT02760888
Recruitment Status : Unknown
Verified December 2015 by Ahmed Elsayed Hassan Elbohoty, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : May 4, 2016
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Elsayed Hassan Elbohoty, Ain Shams University

Tracking Information
First Submitted Date  ICMJE April 30, 2016
First Posted Date  ICMJE May 4, 2016
Last Update Posted Date May 4, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • Pain during the procedure [ Time Frame: intraoperative ]
    Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy
  • pain after the procedure [ Time Frame: 15 minutes after completing the procedure ]
    15 minutes after procedure using a 100mm line visual analog scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
Adverse effect and difficulties [ Time Frame: 24 hours ]
Recorded in Case Record Form
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 Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy:
Official Title  ICMJE Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial
Brief Summary The purpose of this study is there difference between the effect of Tramadol orally and Diclofenac orally with respect to : analgesic efficacy during diagnostic hysteroscopy in nulliparous women.
Detailed Description

This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital- Early Cancer Detection Unite [ECDU].

Patients fulfilling inclusion and exclusion criteria will be divided into three groups.

Group A (study group) Include 34 patients who will receive Tramadol 100mg orally 1 hour before the procedure.

Group B (study group) Include 34 patients who will receive Diclofenac 100mg orally 1 hour before the procedure.

Group C (control group) Include 34 patients who will receive a placebo.

Pain will evaluate on two separate occasion: immediately after the procedure and 15 minutes after procedure using a 100mm line visual analog scale.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Pain, Procedure
Intervention  ICMJE
  • Drug: Tramadol
    Women will receive a oral Tramadol 100mg 1 hour before the procedure
  • Drug: Diclofenac
    Women will receive oral Diclofenac 100mg 1 hour before the procedure
  • Drug: Placebo
    Women will receive a Placebo 1 hour before the procedure
Study Arms  ICMJE
  • Active Comparator: Tramadol
    Women will receive oral tramadol 100 mg 1 hour before the procedure
    Intervention: Drug: Tramadol
  • Active Comparator: Diclofenac
    Women will receive 100 mg diclofenac 1 hour before the procedure
    Intervention: Drug: Diclofenac
  • Placebo Comparator: Placebo
    Women will receive a placebo 1 hour before the procedure
    Intervention: Drug: Placebo
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI raging between (18.5 - 30 ).
  • Scheduled for diagnostic hysteroscopy only.
  • All of them should have given informed written consent.

Exclusion Criteria:

  • Any contraindication to hysteroscopy (e.g. suspected pregnancy, genital tract infection).
  • Receiving any other form of analgesia.
  • Patients with known cervical stenosis, polyps and ulcers.
  • Previous cervical surgery.
  • Patients who are planning to have invasive intrauterine therapeutic interventions during the hysteroscopy.
  • known sensitivity to non-steroidal anti-inflammatory and opioids drugs.
  • Known gastritis or peptic ulcer or cardiac disease or Respiratory dysfunction.
  • Unwilling to comply with the protocol, and Participation in another clinical trial in the last three months prior to the start of this study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760888
Other Study ID Numbers  ICMJE EDCU HY
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Elsayed Hassan Elbohoty, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date December 2015

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