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

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ClinicalTrials.gov Identifier: NCT03868137
Recruitment Status : Not yet recruiting
First Posted : March 8, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Chensi Ouyang, 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.

Condition or disease Intervention/treatment Phase
Pelvic Pain IUD Drug: Ibuprofen Drug: Placebos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A randomization sequence will be generated and given to the research pharmacist who will dispense the appropriate medications to the participants in each arm. Only the pharmacist will know which patient is in which trial arm until the study has ended and data has been analyzed.
Primary Purpose: Treatment
Official Title: Multi-dose Ibuprofen Prophylaxis for IUD-insertion (MIPI): A Triple Blinded
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Placebo Comparator: Placebo
3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion
Drug: Placebos
Placebo

Experimental: 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.
Drug: Ibuprofen
3 doses of Ibuprofen 800 mg




Primary Outcome Measures :
  1. Pain at time of IUD insertion [ Time Frame: 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 :
  1. Pain at 1 day after IUD insertion [ Time Frame: 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

  2. Usage of other medications or methods to decrease post-IUD insertion pain [ Time Frame: 1 day after IUD insertion ]
    Names of other medications or methods



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patient must be female since IUDs are female contraception.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868137


Contacts
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Contact: Chensi Ouyang, MD 407-631-1000 chensi.ouyang@va.gov

Sponsors and Collaborators
Orlando VA Medical Center

Publications of Results:
Other Publications:

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Responsible Party: Chensi Ouyang, Physician, Orlando VA Medical Center
ClinicalTrials.gov Identifier: NCT03868137     History of Changes
Other Study ID Numbers: 1335793-1
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chensi Ouyang, Orlando VA Medical Center:
NSAID
Intrauterine Devices
Ibuprofen
Pelvic pain
Additional relevant MeSH terms:
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Ibuprofen
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action