Status:
COMPLETED
Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
Lead Sponsor:
Robert Hickey
Conditions:
Headache
Migraine
Eligibility:
All Genders
7-17 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Chief complaint of headache
- Age 7-17 years
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00680823
Start Date
January 1 2009
End Date
June 1 2016
Last Update
February 26 2018
Active Locations (1)
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1
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213