Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department

NCT01534806 | Withdrawn Phase 4 DMC

• 1 other identifier: 110808
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (1)

• Reduction in the patient's pain score at 60 minutes from administration of the study medications

  60 minutes from administration of the study medications

Secondary Outcomes (5)

• 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

  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

Study Arms (2)

ketorolac

EXPERIMENTAL

Drug: Ketorolac

Placebo

PLACEBO COMPARATOR

Placebo IV push

Drug: Placebo

Interventions

Ketorolac DRUG

Ketorolac(0.5mg/kg) IV push

ketorolac

Placebo DRUG

Sodium Chloride 0.9% - 10 mL IV push

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patient aged 8-18 years presenting to Akron Children's Hospital (ACH) ED with complaint of headache
• patient has an established diagnosis of migraine without aura or as established by history meets the criteria for migraine headache as defined by the International Criteria for Headache Disorder -II in 2004 a. At least 5 episodes of headache b. The headache should last between 1-72 hours c. The headache should include two of the following: i. Unilateral location, though may be bifrontal or frontotemporal in location but should not be occipital ii. Pulsing quality iii. Moderate to severe pain iv. Aggravation by or causing avoidance of routine physical activity d. One of the following symptoms should accompany the headache i. Nausea or vomiting ii. Photophobia or phonophobia e. The headache should not be attributed to another disorder based on history, physical and/or laboratory information.

You may not qualify if:

• Patients with a contraindication to receiving prochlorperazine, ketorolac, diphenhydramine, or naproxen
• Patients unable to complete the pain scale.
• Patients on medications that will have a drug-drug interaction with the study medication including prochlorperazine, ketorolac, diphenhydramine or naproxen.
• Patients with any medical condition that may be contributing or associated with the current headache such as concussion or trauma
• Female patients with a positive urine HCG point of care test
• Patients with diagnosis of or suspected to have chronic daily headaches defined as a headache lasting at least 4 hours for more than 15 days a month for the past 3 months.
• Patients who received prochlorperazine or ketorolac in the past 48 hours.
• Patients who had previously been randomized in this study in the past 3 months.

Sponsors & Collaborators

• Akron Children's Hospital: lead

Study Sites (1)

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Related Publications (14)

• 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.

  PMID: 10759899 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.

  PMID: 10759922 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.

  PMID: 11554952 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.

  PMID: 15548924 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.

  PMID: 9008503 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.

  PMID: 2915441 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.

  PMID: 7486359 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.

  PMID: 9660282 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.

  PMID: 11335783 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.

  PMID: 14747817 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.

  PMID: 19150192 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.

  PMID: 21296523 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.

  PMID: 3662987 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.

  PMID: 10506669 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• sarah Kline-Krammes, MD

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: February 17, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2012
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (1)