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Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Primary Purpose

Headache, Migraine

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ropivacaine

Normal saline

About this trial

This is an interventional treatment trial for Headache focused on measuring Headache, Migraine, Ropivacaine

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Children's Hospital of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Ropivacaine Injections

Normal Saline Injections

Observation

Arm Description

Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.

Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.

Observation for 30 minutes.

Outcomes

Primary Outcome Measures

The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.

Secondary Outcome Measures

Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision

Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study

Full Information

NCT ID

NCT00680823

First Posted

May 16, 2008

Last Updated

February 22, 2018

Sponsor

Robert Hickey

1. Study Identification

Unique Protocol Identification Number

NCT00680823

Brief Title

Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Robert Hickey

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Migraine

Keywords

Headache, Migraine, Ropivacaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ropivacaine Injections

Arm Type

Experimental

Arm Description

Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.

Arm Title

Normal Saline Injections

Arm Type

Placebo Comparator

Arm Description

Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.

Arm Title

Observation

Arm Type

No Intervention

Arm Description

Observation for 30 minutes.

Intervention Type

Drug

Intervention Name(s)

Ropivacaine

Intervention Description

1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.

Primary Outcome Measure Information:

Title

The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision

Time Frame

3 hours

Title

Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Sieminski, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

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