CompletedNCT02714231Updated Jul 19, 2017

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

A Phase 4 interventional study of diclofenac sodium (cataflam) and hyoscine butyl bromide (buscopan) in Family Planning, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-07-19.

Sponsored by Assiut University · Phase 4, Interventional, and Prevention

Phase: Phase 4
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 20 Years to 50 Years
Sex: Female

Study 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.

Conditions studied

Family Planning

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 50 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

Exclusion Criteria:

Any contraindication to intrauterine device placement

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 100 participants (actual)

Study arms

Experimental
diclofenac
oral diclofuhenac sodium
Drug: diclofenac sodium (cataflam)
Active comparator
hyoscine
oral hyoscine butyl bromide
Drug: hyoscine butyl bromide (buscopan)

Interventions

Drugdiclofenac 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
Drughyoscine 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 researchers measure

Primary outcomes

Mean pain score during insertion
Time frame: intraoperative

Secondary outcomes

Patient satisfaction score
Time frame: 5 minutes

Study locations

1 site

Ahmed Abbas
Assiut, Cairo 002, Egypt

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02714231
Lead sponsor: Assiut University
Responsible party: Ahmed Mohamed Abbas (Dr, Assiut University) — Principal investigator
First posted: Mar 21, 2016
Start date: Mar 2016
Primary completion: Feb 2017
Completion: Mar 2017
Last update: Jul 19, 2017

Study contacts

ahmed abbas, MD

principal investigator · Woman health hospital Assiut

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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