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The aim of this study is to evaluate whether the use of prochlorperazine and ketorolac in combination lead in a larger reduction in pain score compared to prochlorperazine alone when treating pediatric migraine in the Emergency Department (ED). Our hypothesis is that this combination of medications treats not only the pain but also the associated gastrointestinal symptoms of migraine. The main outcome of this study is the reduction in the patient's pain score at 60 minutes from administration of the study medications. Secondary outcomes include the number of patients achieving complete resolution of the headache while in the ED, the number of patients requiring additional treatment interventions by the treating physician, the number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia, the recurrence of headache in the 48-72 hours after discharge, and side effects of the medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketorolac | Experimental |
| |
| Placebo | Placebo Comparator | Placebo IV push |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Ketorolac(0.5mg/kg) IV push |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the patient's pain score at 60 minutes from administration of the study medications | 60 minutes from administration of the study medications |
| Measure | Description | Time Frame |
|---|---|---|
| number of patients achieving complete resolution of the headache while in the emergency department. | while in the emergency department, an expected average of 2 hours. | |
| number of patients requiring additional treatment interventions by the treating physician |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| sarah Kline-Krammes, MD | Akron Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10759899 | Background | Kan L, Nagelberg J, Maytal J. Headaches in a pediatric emergency department: etiology, imaging, and treatment. Headache. 2000 Jan;40(1):25-9. doi: 10.1046/j.1526-4610.2000.00004.x. | |
| 10759922 | Background | Lewis DW, Qureshi F. Acute headache in children and adolescents presenting to the emergency department. Headache. 2000 Mar;40(3):200-3. doi: 10.1046/j.1526-4610.2000.00029.x. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Sodium Chloride 0.9% - 10 mL IV push |
|
| while in the emergency department, an expected average of 2 hours. |
| number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia | while in the emergency department, an expected average of 2 hours. |
| recurrence of headache | 48-72 hours after discharge |
| side effects of medications | 48-72 hours after discharge |
| 11554952 | Background | Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001 Jul-Aug;41(7):646-57. doi: 10.1046/j.1526-4610.2001.041007646.x. |
| 15548924 | Background | Lewis DW. Toward the definition of childhood migraine. Curr Opin Pediatr. 2004 Dec;16(6):628-36. doi: 10.1097/01.mop.0000143763.17125.03. |
| 9008503 | Background | Hamalainen ML, Hoppu K, Valkeila E, Santavuori P. Ibuprofen or acetaminophen for the acute treatment of migraine in children: a double-blind, randomized, placebo-controlled, crossover study. Neurology. 1997 Jan;48(1):103-7. doi: 10.1212/wnl.48.1.103. |
| 2915441 | Background | Jones J, Sklar D, Dougherty J, White W. Randomized double-blind trial of intravenous prochlorperazine for the treatment of acute headache. JAMA. 1989 Feb 24;261(8):1174-6. |
| 7486359 | Background | Coppola M, Yealy DM, Leibold RA. Randomized, placebo-controlled evaluation of prochlorperazine versus metoclopramide for emergency department treatment of migraine headache. Ann Emerg Med. 1995 Nov;26(5):541-6. doi: 10.1016/s0196-0644(95)70001-3. |
| 9660282 | Background | Seim MB, March JA, Dunn KA. Intravenous ketorolac vs intravenous prochlorperazine for the treatment of migraine headaches. Acad Emerg Med. 1998 Jun;5(6):573-6. doi: 10.1111/j.1553-2712.1998.tb02463.x. |
| 11335783 | Background | Kabbouche MA, Vockell AL, LeCates SL, Powers SW, Hershey AD. Tolerability and effectiveness of prochlorperazine for intractable migraine in children. Pediatrics. 2001 Apr;107(4):E62. doi: 10.1542/peds.107.4.e62. |
| 14747817 | Background | Brousseau DC, Duffy SJ, Anderson AC, Linakis JG. Treatment of pediatric migraine headaches: a randomized, double-blind trial of prochlorperazine versus ketorolac. Ann Emerg Med. 2004 Feb;43(2):256-62. doi: 10.1016/s0196-0644(03)00716-9. |
| 19150192 | Background | Trottier ED, Bailey B, Dauphin-Pierre S, Gravel J. Clinical outcomes of children treated with intravenous prochlorperazine for migraine in a pediatric emergency department. J Emerg Med. 2010 Aug;39(2):166-73. doi: 10.1016/j.jemermed.2008.08.012. Epub 2009 Jan 15. |
| 21296523 | Background | Trottier ED, Bailey B, Lucas N, Lortie A. Prochlorperazine in children with migraine: a look at its effectiveness and rate of akathisia. Am J Emerg Med. 2012 Mar;30(3):456-63. doi: 10.1016/j.ajem.2010.12.020. Epub 2011 Feb 5. |
| 3662987 | Background | McGrath PA. The multidimensional assessment and management of recurrent pain syndromes in children. Behav Res Ther. 1987;25(4):251-62. doi: 10.1016/0005-7967(87)90003-9. No abstract available. |
| 10506669 | Background | Chambers CT, Giesbrecht K, Craig KD, Bennett SM, Huntsman E. A comparison of faces scales for the measurement of pediatric pain: children's and parents' ratings. Pain. 1999 Oct;83(1):25-35. doi: 10.1016/s0304-3959(99)00086-x. |
| D009422 | Nervous System Diseases |
| D006571 | Heterocyclic Compounds |