Ropivacaine Intramuscular Paracervical Injections for Pediatric Headache: A Randomized Placebo-Controlled Trial - 29/08/17
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.
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| Please see page 324 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Jocelyn Gravel, MD |
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| Author contributions: KC, KAC, and RWH conceived the study and designed the trial. KC obtained research funding. SKY, KC, and RWH supervised the conduct of the trial and data collection. RWH chaired the data oversight committee. SKY, MCP, KC, and RWH undertook recruitment of participants and managed the data, including quality control. SKY, MCP, and RWH analyzed the data. SKY drafted the article and all authors contributed to its revision. RWH takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). The authors have stated that no such relationships exist. This project was supported in part by a grant from the National Headache Foundation. Additionally, statistical support was provided by the University of Pittsburgh’s Clinical and Translational Science Institute, which is funded in part by the National Institutes of Health through grant UL1-TR-000005. |
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| Trial registration number: NCT00680823 |
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Vol 70 - N° 3
P. 323-330 - septembre 2017 Retour au numéro
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