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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680823
Other study ID # PRO08030283
Secondary ID
Status Completed
Phase N/A
First received May 16, 2008
Last updated February 22, 2018
Start date January 2009
Est. completion date June 2016

Study information

Verified date February 2018
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ropivacaine
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Normal saline
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Locations

Country Name City State
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Robert Hickey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. 30 minutes
Secondary Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision 3 hours
Secondary Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study 72 hours
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