Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
Methods: The study will be a double-blind randomized control trial. Patients will be randomly assigned to receive either intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side, placebo injections with 1 mL normal saline on each side, or no intervention at all. If randomized to an injection, the investigator and the patient will both be blinded as to the nature of the injection. The location of the child's pain as well as severity will be assessed immediately prior to intervention and every 10 minutes for 30 minutes. If after 30 minutes relief is insufficient for discharge to home, intravenous treatment will be instituted according to current protocol. Pain will be reassessed at the time of ultimate disposition. The scale used to assess severity will vary based on the child's age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.
Time frame: 30 minutes
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision
Time frame: 3 hours
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study
Time frame: 72 hours
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