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Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00680823
First Posted: May 20, 2008
Last Update Posted: June 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Susan Sieminski, MD, Children's Hospital of Pittsburgh
  Purpose
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.

Condition Intervention
Headache Migraine Drug: Ropivacaine Drug: Normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?

Resource links provided by NLM:


Further study details as provided by Susan Sieminski, MD, Children's Hospital of Pittsburgh:

Primary Outcome Measures:
  • The primary outcome will be pain relief sufficient for discharge from the emergency department. [ Time Frame: 3 hours ]

Secondary Outcome Measures:
  • complete resolution of headache [ Time Frame: 3 hours ]
  • admission [ Time Frame: 3 hours ]
  • time from presentation to ultimate disposition [ Time Frame: 3 hours ]
  • re-presentation to the emergency department with headache within 72 hours of participating in the study [ Time Frame: 72 hours ]
  • a change of greater than 1.5 on the numerical rating scale [ Time Frame: 3 hours ]

Enrollment: 150
Study Start Date: January 2009
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine Injections
Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.
Drug: Ropivacaine
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Placebo Comparator: Normal Saline Injections
Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.
Drug: Normal saline
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
No Intervention: Observation
Observation for 30 minutes.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680823


Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Susan Sieminski, MD University of Pittsburgh
  More Information

Responsible Party: Susan Sieminski, MD, Pediatric Emergency Medicine Fellow, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00680823     History of Changes
Other Study ID Numbers: PRO08030283
First Submitted: May 16, 2008
First Posted: May 20, 2008
Last Update Posted: June 28, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Susan Sieminski, MD, Children's Hospital of Pittsburgh:
Headache
Migraine
Ropivacaine

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents