INDO-IUD: Indomethacin Use in Pain Relief During Intrauterine Device Insertion

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02711358

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the investigators study is to test the analgesic effect of rectal indomethacin during Intrauterine device insertion.

Condition or Disease	Intervention/Treatment	Phase
Family Planning	Drug: indomethacin suppositories Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Rectal Indomethacin Use in Pain Relief During Intrauterine Device Insertion: A Randomized Controlled Trial

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: indomethacin indomethacin suppositories	Drug: indomethacin suppositories The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure
Placebo Comparator: placebo placebo suppositories	Drug: placebo The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

Arm

Intervention/Treatment

Experimental: indomethacin

indomethacin suppositories

Drug: indomethacin suppositories

The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure

Placebo Comparator: placebo

placebo suppositories

Drug: placebo

The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure

Outcome Measures

Primary Outcome Measures

Mean pain score during IUD insertion [intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Dr, Assiut University

ClinicalTrials.gov Identifier:

NCT02711358

Other Study ID Numbers:

INDO

First Posted:

Mar 17, 2016

Last Update Posted:

Nov 29, 2016

Last Verified:

Nov 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Indomethacin

Study Results

No Results Posted as of Nov 29, 2016