Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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
Study Start Date: January 2009
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine Injections
Intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side.
Drug: Ropivacaine
1 mL IM to each side in to the lower paraspinous muscles x 1.
Placebo Comparator: Normal Saline Injections
Intramuscular injection of the lower cervical paraspinous muscles with 1 mL of normal saline on each side.
Drug: Normal saline
1 mL IM to each side in to the lower 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

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680823

Contacts
Contact: Susan K Sieminski, MD 412-692-7980 susan.sieminski@chp.edu
Contact: Robert Hickey, MD (412) 692-7972 robert.hickey@chp.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Susan Sieminski, MD    412-692-7980    Susan.Sieminski@chp.edu   
Contact: Robert Hickey, MD    (412) 692-7972    robert.hickey@chp.edu   
Principal Investigator: Susan Sieminski, MD         
Sponsors and Collaborators
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Susan Sieminski, MD Children's Hospital of Pittsburgh
  More Information

No publications provided

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
Study First Received: May 16, 2008
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014