IUD, Pelvic Pain
Conditions
Keywords
NSAID, Intrauterine Devices, Ibuprofen, Pelvic pain
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.
Interventions
DRUGIbuprofen
3 doses of Ibuprofen 800 mg
DRUGPlacebos
Placebo
Sponsors
Orlando VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Usage of other medications or methods to decrease post-IUD insertion pain | 1 day after IUD insertion | Names of other medications or methods |
Countries
United States
Contacts
Primary ContactChensi Ouyang, MD
Outcome results
None listed