Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

NCT ID: NCT00680823

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2016-06-30

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 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.

Conditions

Headache; Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine Injections

Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Normal Saline Injections

Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Observation

Observation for 30 minutes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ropivacaine

1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Intervention Type: DRUG

Normal saline

1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Hickey

OTHER

Sponsor Role: lead

Responsible Party

Robert Hickey

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Susan Sieminski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO08030283

Identifier Type: -

Identifier Source: org_study_id