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Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?
This study is not yet open for participant recruitment.
Verified by Children's Hospital of Pittsburgh, May 2008
Sponsored by: Children's Hospital of Pittsburgh
Information provided by: Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier: NCT00680823
  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

Genetics Home Reference related topics: familial hemiplegic migraine
MedlinePlus related topics: Headache Migraine
Drug Information available for: Sodium chloride Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complete resolution of headache [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • admission [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • time from presentation to ultimate disposition [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • re-presentation to the emergency department with headache within 72 hours of participating in the study [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • a change of greater than 1.5 on the numerical rating scale [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Arms Assigned Interventions
A: Experimental
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 paraspinous muscles x 1.
B: Placebo Comparator
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 paraspinous muscles x 1.
C: No Intervention
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 1.5 mL of 0.5% ropivacaine on each side, placebo injections with 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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Chief complaint of headache
  • Age 5-18 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680823

Contacts
Contact: Kerry Caperell, MD 412-692-5325 kerry.caperell@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Children's Hospital of Pittsburgh
  More Information

Responsible Party: Children's Hospital of Pittsburgh ( Kerry Caperell, MD / Fellow - pediatric emergency medicine )
Study ID Numbers: PRO08030283
Study First Received: May 16, 2008
Last Updated: May 19, 2008
ClinicalTrials.gov Identifier: NCT00680823  
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Pittsburgh:
Headache
Migraine
Ropivacaine

Study placed in the following topic categories:
Signs and Symptoms
Ropivacaine
Migraine Disorders
Headache
Central Nervous System Diseases
Neurologic Manifestations
Emergencies
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 14, 2009