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Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department? - NCT00680823-15213(Clinical Trial 222199)



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City:  Pittsburgh
State:  
PA
Zip Code: 15213
Conditions: Headache - Migraine
Purpose: Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
Study summary: 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.
Criteria: Inclusion Criteria: - Chief complaint of headache - Age 5-18 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
Study is available at: Children's Hospital of Pittsburgh
Pittsburgh, PA 15213
United States

Primary Contact:
Kerry Caperell, MD
Email: kerry.caperell@chp.edu
Phone: 412-692-5325

Secondary Contact:
Kerry Caperell, MD
Email: kerry.caperell@chp.edu
Phone: 412-692-5325
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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