Multi-dose Ibuprofen Prophylaxis for IUD-insertion

Not Applicable

• Conditions: Pelvic Pain; IUD
• Interventions: Drug: Placebos; Drug: Ibuprofen

• Registration Number: NCT03868137
• Lead Sponsor: Orlando VA Medical Center

Brief Summary

This study compares the effectiveness of decreasing pain at time of and day after intrauterine device (IUD) insertion when patients take three doses of Ibuprofen versus three doses of placebo.

Detailed Description

Ibuprofen is commonly used over the counter and prescribed for pain relief such as menstrual cramps. Intrauterine (IUD) insertion can cause pain during and after the insertion. Currently, studies have found that single dose of Ibuprofen take prior to IUD insertion does decrease pain at time of IUD insertion. This study will examine whether 3 doses of Ibuprofen can decrease pain at time of and 1 day after IUD insertion.

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-08
• Study Start: 2020-09-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-09
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Age ≥ 18
• Female
• Able to provide informed consent
• English speaking
• Able to provide telephone and address contact information
• Able and willing to receive HIPAA compliant telephone texts and phone messages
• Stable (the same) address and phone number within the last 6 months.

Exclusion Criteria

• Contraindications to IUD insertion (active pelvic infection, current pregnancy)
• Contraindications to NSAIDs (allergy, history of asthma, history of aspirin allergy, history of kidney disease, history of stomach ulcer, history of active GI bleeding, history of liver disease)
• Not undergoing any other concurrent office procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion
Ibuprofen	Ibuprofen	3 doses of Ibuprofen 800 mg will be given to patients starting 1 day before IUD insertion. Patient will take 800 mg Ibuprofen at noon and 8 PM day before IUD insertion and at 8 AM on the day of IUD insertion.

Primary Outcome Measures

Name	Time	Method
Pain at time of IUD insertion	At time of IUD insertion	Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain

Secondary Outcome Measures

Name	Time	Method
Usage of other medications or methods to decrease post-IUD insertion pain	1 day after IUD insertion	Names of other medications or methods
Pain at 1 day after IUD insertion	1 day after IUD insertion	Pain score measured on 10 point visual analog scale (VAS): 0-3 mild pain, 4-7 moderate pain, 8-10 severe pain

Trial Locations

Locations (1)

Orlando VA Medical Center; 🇺🇸 Orlando, Florida, United States