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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Children's Hospital of Pittsburgh.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Children's Hospital of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00680823

First received: May 16, 2008

Last updated: July 13, 2011

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

July 13, 2011

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary outcome will be pain relief sufficient for discharge from the emergency department. [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00680823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Headache
Migraine

Intervention ^ICMJE

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.

Study Arm (s)

Experimental: A
Intramuscular injection of the lower cervical paraspinous muscles with 1 mL of 0.5% ropivacaine on each side.

Intervention: Drug: Ropivacaine
Placebo Comparator: B
Intramuscular injection of the lower cervical paraspinous muscles with 1 mL of normal saline on each side.

Intervention: Drug: Normal saline
No Intervention: C
Observation for 30 minutes.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Not Provided

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.
history of shunt or other intracranial hardware

Gender

Both

Ages

7 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kerry Caperell, MD

412-692-5325

kerry.caperell@chp.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00680823

Other Study ID Numbers ^ICMJE

PRO08030283

Has Data Monitoring Committee

Yes

Responsible Party

Kerry Caperell, MD / Fellow - pediatric emergency medicine, Children's Hospital of Pittsburgh

Study Sponsor ^ICMJE

Children's Hospital of Pittsburgh

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kerry Caperell, MD

Children's Hospital of Pittsburgh

Information Provided By

Children's Hospital of Pittsburgh

Verification Date

September 2010

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