View Clinical Trial (Medical Research Study)
Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Headache - Migraine |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00680823 |
| Primary Contact: |
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Principal Investigator
Kerry Caperell, MD
Children's Hospital of Pittsburgh
Kerry Caperell, MD
Phone: 412-692-5325
Email: kerry.caperell@chp.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Kerry Caperell, MD
Phone: 412-692-5325
Email: kerry.caperell@chp.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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