N/A
N=150
Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
Headache · Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00680823 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. — 16; 14; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ropivacaine (Drug); Normal saline (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Robert Hickey
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. |
16; 14; 2 | — |
| SECONDARY Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision |
10; 10; 12 | — |
| SECONDARY Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study |
7; 7; 4 | — |
Summary
Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
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
Data sourced from ClinicalTrials.gov (NCT00680823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.