Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches, Hospital |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 12/15/2017 |
| Start Date: | January 2009 |
| End Date: | June 2016 |
Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an
effective treatment for pediatric headache in an emergency department setting.
effective treatment for pediatric headache in an emergency department setting.
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.
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.
Inclusion Criteria:
- Chief complaint of headache
- Age 7-17 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
We found this trial at
1
site
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Susan Sieminski, MD
Phone: 412-692-7980
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