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Sponsored by: |
Children's Hospital of Pittsburgh |
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Information provided by: | Children's Hospital of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00680823 |
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
Condition | Intervention |
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Headache Migraine |
Drug: Ropivacaine Drug: Normal saline |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 150 |
Arms | Assigned Interventions |
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A: Experimental
Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.
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Drug: Ropivacaine
1.5 mL IM to each side in to the lower paraspinous muscles x 1.
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B: Placebo Comparator
Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.
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Drug: Normal saline
1.5 mL IM to each side in to the lower paraspinous muscles x 1.
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C: No Intervention
Observation for 30 minutes.
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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 1.5 mL of 0.5% ropivacaine on each side, placebo injections with 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.
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kerry Caperell, MD | 412-692-5325 | kerry.caperell@chp.edu |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 |
Responsible Party: | Children's Hospital of Pittsburgh ( Kerry Caperell, MD / Fellow - pediatric emergency medicine ) |
Study ID Numbers: | PRO08030283 |
Study First Received: | May 16, 2008 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00680823 |
Health Authority: | United States: Institutional Review Board |
Headache Migraine Ropivacaine |
Signs and Symptoms Ropivacaine Migraine Disorders Headache Central Nervous System Diseases Neurologic Manifestations |
Emergencies Headache Disorders, Primary Pain Brain Diseases Headache Disorders |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |