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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3 doses of placebo identical to study drug will be given to patients starting 1 day before IUD insertion |
|
| Ibuprofen | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 3 doses of Ibuprofen 800 mg |
| |
| Placebos |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patient must be female since IUDs are female contraception.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chensi Ouyang, MD | Contact | 407-631-1000 | chensi.ouyang@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando VA Medical Center | Recruiting | Orlando | Florida | 32827 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26444110 | Background | Kavanaugh ML, Jerman J, Finer LB. Changes in Use of Long-Acting Reversible Contraceptive Methods Among U.S. Women, 2009-2012. Obstet Gynecol. 2015 Nov;126(5):917-927. doi: 10.1097/AOG.0000000000001094. | |
| 16824298 | Background | Asker C, Stokes-Lampard H, Beavan J, Wilson S. What is it about intrauterine devices that women find unacceptable? Factors that make women non-users: a qualitative study. J Fam Plann Reprod Health Care. 2006 Apr;32(2):89-94. doi: 10.1783/147118906776276170. |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Triple blind randomized control trial involving placebo arm and intervention arm (Ibuprofen)
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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.
| Drug |
Placebo |
|
Names of other medications or methods
| 1 day after IUD insertion |
| 16484309 | Background | Hubacher D, Reyes V, Lillo S, Pierre-Louis B, Zepeda A, Chen PL, Croxatto H. Preventing copper intrauterine device removals due to side effects among first-time users: randomized trial to study the effect of prophylactic ibuprofen. Hum Reprod. 2006 Jun;21(6):1467-72. doi: 10.1093/humrep/del029. Epub 2006 Feb 16. |
| 9846090 | Background | Jensen HH, Blaabjerg J, Lyndrup J. [Prophylactic use of prostaglandin synthesis inhibitors in connection with IUD insertion]. Ugeskr Laeger. 1998 Nov 23;160(48):6958-61. Danish. |
| 22176793 | Background | Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial. Contraception. 2012 Jun;85(6):558-62. doi: 10.1016/j.contraception.2011.10.015. Epub 2011 Dec 15. |
| 25487172 | Background | Bednarek PH, Creinin MD, Reeves MF, Cwiak C, Espey E, Jensen JT; Post-Aspiration IUD Randomization (PAIR) Study Trial Group. Prophylactic ibuprofen does not improve pain with IUD insertion: a randomized trial. Contraception. 2015 Mar;91(3):193-7. doi: 10.1016/j.contraception.2014.11.012. Epub 2014 Nov 25. |
| 4612152 | Background | Massey SE, Varady JC, Henzl MR. Pain relief with naproxen following insertion of an intrauterine device. J Reprod Med. 1974 Dec;13(6):226-31. No abstract available. |
| 26241253 | Background | Ngo LL, Ward KK, Mody SK. Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):29-36. doi: 10.1097/AOG.0000000000000912. |
| 27824753 | Background | Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746. |
| 21477680 | Result | Trussell J. Contraceptive failure in the United States. Contraception. 2011 May;83(5):397-404. doi: 10.1016/j.contraception.2011.01.021. Epub 2011 Mar 12. |
| 25924648 | Result | Lethaby A, Hussain M, Rishworth JR, Rees MC. Progesterone or progestogen-releasing intrauterine systems for heavy menstrual bleeding. Cochrane Database Syst Rev. 2015 Apr 30;(4):CD002126. doi: 10.1002/14651858.CD002126.pub3. |