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

A Randomized Controlled Trial of 2 Different Methods for Pain Relief During Intrauterine Device Insertion

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

Study Overview

• Status: Completed
• Conditions: Family Planning
• Intervention / Treatment: Drug: diclofenac sodium (cataflam); Drug: hyoscine butyl bromide (buscopan)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean pain score during insertion	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction score	5 minutes

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: ahmed abbas, MD, Woman health hospital Assiut

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 16, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 15, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Adjuvants, Anesthesia; Anticonvulsants; Mydriatics; Diclofenac; Bromides; Scopolamine; Butylscopolammonium Bromide
• Other Study ID Numbers: DS-HB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes