Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

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

Detailed Description
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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.

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

Conditions
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Headache, Migraine

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chief complaint of headache Age 7-17 years Exclusion Criteria: Presence of fever meningismus headache that wakes the child at night known organic brain disease, mass, or tumor history of stroke history of allergy to ropivacaine or other aminoacyl local anesthetics history of liver disease history of impaired cardiac function abnormal neurologic signs a focal neurologic abnormality on exam that is not a known component of the child's headache syndrome cognitive inability to communicate the intensity of pain. history of shunt or other intracranial hardware

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine Injections<br>Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. | Drug: Ropivacaine<br>* 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.<br>|
| Placebo Comparator: Normal Saline Injections<br>Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. | Drug: Normal saline<br>* 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.<br>|
| No Intervention: Observation<br>Observation for 30 minutes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision |  | 3 hours | 
| Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache, Migraine, Ropivacaine