Conditions: Headache Migraine
Keywords: Headache Migraine Ropivacaine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: yes

Brief summary:
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.

Detailed description:
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.

Arms:
arm 1: Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. arm 2: Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. arm 3: Observation for 30 minutes.

Interventions: intervention 1: Ropivacaine intervention 2: Normal saline
Intervention descriptions: intervention 1: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. intervention 2: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Protocol document: