Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

NCT00680823 | Completed Results DMC

• 1 other identifier: PRO08030283
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Headache; Migraine

Keywords

Headache; Migraine; Ropivacaine

Outcome Measures

Primary Outcomes (1)

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

  30 minutes

Secondary Outcomes (2)

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

  3 hours

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

  72 hours

Study Arms (3)

Ropivacaine Injections

EXPERIMENTAL

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

Drug: Ropivacaine

Normal Saline Injections

PLACEBO COMPARATOR

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

Drug: Normal saline

Observation

NO INTERVENTION

Observation for 30 minutes.

Interventions

Ropivacaine DRUG

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

Ropivacaine Injections

Normal saline DRUG

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

Normal Saline Injections

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Chief complaint of headache
• Age 7-17 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Hickey: lead

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Robert Hickey
• Organization: Children's Hospital of Pittsburgh

robert.hickey@chp.edu

412 692 7692

Study Officials

• Susan Sieminski, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 20, 2008
• Study Start: January 1, 2009
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 26, 2018
• Results First Posted: December 13, 2017

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)