NCT00680823

Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Robert Hickey · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Headache
• Migraine

Interventions

Type	Name	Description
DRUG	Ropivacaine	1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
DRUG	Normal saline	1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Timeline

• Start date: 2009-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2008-05-20
• Last updated: 2018-02-26
• Results posted: 2017-12-13

Locations

1 site across 1 country: United States