Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Migraine Clinical Trial

Official title:

Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680823
• Other study ID #: PRO08030283
• 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
• 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

Related Conditions & MeSH terms

• Headache
• Migraine
• Migraine Disorders

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