Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Not Applicable

Completed

• Conditions: Headache; Migraine
• Interventions: Drug: Normal saline; Drug: Ropivacaine

• Registration Number: NCT00680823
• Lead Sponsor: Robert Hickey

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.

Study Timeline

• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-20
• Study Start: 2009-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-11-16
• Results First Submitted QC: 2017-11-16
• Results First Posted: 2017-12-13
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Chief complaint of headache
• Age 7-17 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline Injections	Normal saline	Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.
Ropivacaine Injections	Ropivacaine	Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	30 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States