Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

This study is currently recruiting participants.
Verified December 2013 by Children's Hospital of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Susan Sieminski, MD, Children's Hospital of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00680823
First received: May 16, 2008
Last updated: December 2, 2013
Last verified: December 2013

May 16, 2008
December 2, 2013
January 2009
July 2014   (final data collection date for primary outcome measure)
The primary outcome will be pain relief sufficient for discharge from the emergency department. [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680823 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
Is Paraspinal Intramuscular Ropivacaine Injection an Effective Treatment for Headache in a Pediatric Emergency Department?

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Headache
  • Migraine
  • Drug: Ropivacaine
    1 mL IM to each side in to the lower paraspinous muscles x 1.
  • Drug: Normal saline
    1 mL IM to each side in to the lower paraspinous muscles x 1.
  • Experimental: Ropivacaine Injections
    Intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side.
    Intervention: Drug: Ropivacaine
  • Placebo Comparator: Normal Saline Injections
    Intramuscular injection of the lower cervical paraspinous muscles with 1 mL of normal saline on each side.
    Intervention: Drug: Normal saline
  • No Intervention: Observation
    Observation for 30 minutes.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
7 Years to 17 Years
Yes
Contact: Susan K Sieminski, MD 412-692-7980 susan.sieminski@chp.edu
Contact: Robert Hickey, MD (412) 692-7972 robert.hickey@chp.edu
United States
 
NCT00680823
PRO08030283
Yes
Susan Sieminski, MD, Children's Hospital of Pittsburgh
Children's Hospital of Pittsburgh
Not Provided
Principal Investigator: Susan Sieminski, MD Children's Hospital of Pittsburgh
Children's Hospital of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP