Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Robert Hickey

Status: Completed

Conditions: Migraine; Headache

Treatments: Drug: Normal saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00680823

PRO08030283

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Ropivacaine Injections

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine

Normal Saline Injections

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline

Observation

No Intervention group

Description:

Observation for 30 minutes.