Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Pain, Procedure Drug: Tramadol Drug: Diclofenac Drug: Placebo Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Oral Tramadol Versus Diclofenac For Pain Relief Before Outpatient Hysteroscopy: A Randomized Controlled Trial
Study Start Date : May 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tramadol
Women will receive oral tramadol 100 mg 1 hour before the procedure
Drug: Tramadol
Women will receive a oral Tramadol 100mg 1 hour before the procedure

Active Comparator: Diclofenac
Women will receive 100 mg diclofenac 1 hour before the procedure
Drug: Diclofenac
Women will receive oral Diclofenac 100mg 1 hour before the procedure

Placebo Comparator: Placebo
Women will receive a placebo 1 hour before the procedure
Drug: Placebo
Women will receive a Placebo 1 hour before the procedure




Primary Outcome Measures :
  1. Pain during the procedure [ Time Frame: intraoperative ]
    Pain will be assessed using a visual analogue scale immediatly after inserting the hysterscopy

  2. pain after the procedure [ Time Frame: 15 minutes after completing the procedure ]
    15 minutes after procedure using a 100mm line visual analog scale


Secondary Outcome Measures :
  1. Adverse effect and difficulties [ Time Frame: 24 hours ]
    Recorded in Case Record Form



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02760888


Contacts
Layout table for location contacts
Contact: Ahmed Elsayed Elbohoty, MD elbohoty79@yahoo.com

Locations
Layout table for location information
Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

Layout table for additonal information
Responsible Party: Ahmed Elsayed Hassan Elbohoty, Assistant professor of Obstetrics and Gynecology Faculty of Medicine Ain Shams University, Ain Shams University
ClinicalTrials.gov Identifier: NCT02760888     History of Changes
Other Study ID Numbers: EDCU HY
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Tramadol
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants