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Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion

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: NCT02714231
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.

Condition or disease Intervention/treatment Phase
Family Planning Drug: diclofenac sodium (cataflam) Drug: hyoscine butyl bromide (buscopan) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion
Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017


Arm Intervention/treatment
Experimental: diclofenac
oral diclofuhenac sodium
Drug: diclofenac sodium (cataflam)
The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure

Active Comparator: hyoscine
oral hyoscine butyl bromide
Drug: hyoscine butyl bromide (buscopan)
The patients in the study group will take one tablet of buscopan 10 mg 30 min before the scheduled time of the procedure




Primary Outcome Measures :
  1. Mean pain score during insertion [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. Patient satisfaction score [ Time Frame: 5 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women not taken analgesics or anxiolytics in the 24 hours prior insertion
  • Women not taken misoprostol prior to intrauterine device insertion
  • Women who will accept to participate in the study

Exclusion Criteria:

  • Any contraindication to intrauterine device placement

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): NCT02714231


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: ahmed abbas, MD Woman health hospital Assiut
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Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02714231    
Other Study ID Numbers: DS-HB
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Diclofenac
Scopolamine
Bromides
Butylscopolammonium Bromide
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
Anticonvulsants
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Muscarinic Antagonists
Parasympatholytics