Ropivacaine Intramuscular Paracervical Injections for Pediatric Headache: A Randomized Placebo-Controlled Trial

Abstract

Study objective: We seek to determine whether ropivacaine cervical paraspinal injections compared with normal saline solution injections provide headache relief to pediatric patients that is sufficient for emergency department (ED) discharge.

Methods: We enrolled children aged 7 to 17 years in a double-blinded, randomized, controlled trial of patients presenting to a pediatric ED with headache. Subjects were randomized into 1 of 3 groups: bilateral cervical paraspinal injections of either (1) 0.5% ropivacaine or (2) normal saline solution, or (3) a natural history group (not blinded) receiving no headache therapy for the first 30 minutes. Pain scores were assessed at enrollment and at 10-, 20-, and 30-minute intervals after the administration of the injections. After the intervention period of 30 minutes, additional therapy was provided as needed. Primary outcome was the proportion of children discharged with adequate pain relief at 30 minutes without additional therapy. Secondary outcomes included reduction in pain scores, reoccurrence of headache, and re-presentation to health care with headache.

Results: One hundred fifty-three children were enrolled. The proportion discharged with adequate pain relief 30 minutes after the injections did not differ between the 2 intervention groups (32% in the ropivacaine group versus 28% in the saline solution group; effect difference 4%; 95% confidence interval -14% to 21%). In contrast, only 4% percent of patients in the natural history group were discharged without additional therapy after the 30-minute assessment. Reduction of pain scores (2.0 and 2.2 in ropivacaine versus saline solution), headache reoccurrence, and return to care was similar between the 2 treatment groups.

Conclusion: Cervical paraspinal injections of either ropivacaine or saline solution were effective for approximately one third of patients.