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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Akron Children's Hospital
Akron, Ohio, United States
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
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.
number of patients requiring additional treatment interventions by the treating physician
Time frame: 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
Time frame: while in the emergency department, an expected average of 2 hours.
recurrence of headache
Time frame: 48-72 hours after discharge
side effects of medications
Time frame: 48-72 hours after discharge
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