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OpenTrials
Completed

NCT Number: NCT00680823

Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

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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Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

normal saline

Drug

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

Primary outcomes

  1. The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.

    Time frame: 30 minutes

Secondary outcomes

  1. Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision

    Time frame: 3 hours

  2. Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Robert Hickey

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
May 20, 2008
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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