The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches. The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
Washington University in St. Louis
St Louis, Missouri, United States
Change from baseline in pain on the 10 point Faces Pain Scale-Revised in 2 hours
The Faces Pain Scale - Revised. This is a 10-point pain scale (0-10) that has been validated for the use in children greater than 4 years of age in the ED; is one of the self-report measures of pain recommended for research in children; and is commonly used as the primary outcome in Emergency Department research. Lower numbers are better outcomes.
Time frame: Baseline (within 15 minutes prior to receiving the study drug or as close to this time frame as possible) and then at 10 minutes, 30 minutes, 60 minutes, and 120 minutes (or as close to this time frame as possible)
Response Rate- 2/10 score difference of pain on the Faces Pain Scale- Revised
Response rate is defined as the number of participants with a pain scale change of at least 2/10 on The Faces Pain Scale - Revised from baseline to 10 minutes after medication given. The Faces Pain Scale - Revised. The Faces Pain Scale - Revised is a 10-point pain scale that has been validated for the use in children greater than 4 years of age in the Emergency Department; is one of the self-report measures of pain recommended for research in children; and is commonly used as the primary outcome in Emergency Department research. The lower numbers on this scale report better outcomes.
Time frame: 10 minutes after medication given
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