Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT00680823
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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Notify Me7 year–17 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Time frame: 30 minutes
Time frame: 3 hours
Time frame: 72 hours
Robert Hickey
Other
Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
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