Multi-dose Ibuprofen Prophylaxis for IUD-insertion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI): A Triple Blinded

Conditions
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Pelvic Pain, IUD

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion | Drug: Placebos<br>* Placebo<br>|
| Experimental: Ibuprofen<br>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. | Drug: Ibuprofen<br>* 3 doses of Ibuprofen 800 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 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 | At time of IUD insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at 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 | 1 day after IUD insertion | 
| Usage of other medications or methods to decrease post-IUD insertion pain | Names of other medications or methods | 1 day after IUD insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAID, Intrauterine Devices, Ibuprofen, Pelvic pain