Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI)

Orlando VA Medical Center

Status: Unknown

Conditions: Pelvic Pain; IUD

Treatments: Drug: Placebos; Drug: Ibuprofen

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03868137

1335793-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion

Treatment:

Drug: Placebos

Ibuprofen

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen