Back to resultsProchlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department
Primary Purpose
Migraine
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring Migraine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Akron Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ketorolac
Placebo
Arm Description
Placebo IV push
Outcomes
Primary Outcome Measures
Reduction in the patient's pain score at 60 minutes from administration of the study medications
Secondary Outcome Measures
number of patients achieving complete resolution of the headache while in the emergency department.
number of patients requiring additional treatment interventions by the treating physician
number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia
recurrence of headache
side effects of medications
Full Information
NCT ID
NCT01534806
First Posted
November 8, 2011
Last Updated
June 23, 2014
Sponsor
Akron Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01534806
Brief Title
Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department
Official Title
A Randomized Double Blinded Study Comparing Use of Prochlorperazine Versus Prochlorperazine and Ketorolac in the Treatment of Pediatric Migraine in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Drug is backordered;
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akron Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketorolac
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IV push
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Ketorolac(0.5mg/kg) IV push
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sodium Chloride 0.9% - 10 mL IV push
Primary Outcome Measure Information:
Title
Reduction in the patient's pain score at 60 minutes from administration of the study medications
Time Frame
60 minutes from administration of the study medications
Secondary Outcome Measure Information:
Title
number of patients achieving complete resolution of the headache while in the emergency department.
Time Frame
while in the emergency department, an expected average of 2 hours.
Title
number of patients requiring additional treatment interventions by the treating physician
Time Frame
while in the emergency department, an expected average of 2 hours.
Title
number of patients with resolution of the associated symptoms like nausea, vomiting, photophobia and phonophobia
Time Frame
while in the emergency department, an expected average of 2 hours.
Title
recurrence of headache
Time Frame
48-72 hours after discharge
Title
side effects of medications
Time Frame
48-72 hours after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sarah Kline-Krammes, MD
Organizational Affiliation
Akron Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10759899
Citation
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.
Results Reference
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PubMed Identifier
10759922
Citation
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.
Results Reference
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PubMed Identifier
11554952
Citation
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.
Results Reference
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PubMed Identifier
15548924
Citation
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.
Results Reference
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PubMed Identifier
9008503
Citation
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.
Results Reference
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PubMed Identifier
2915441
Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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.
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Prochlorperazine Versus Prochlorperazine & Ketorolac in Treatment of Pediatric Migraine in the Emergency Department
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