Headache, Migraine
Conditions
Keywords
Headache, Migraine, Ropivacaine
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.
Interventions
DRUGRopivacaine
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
DRUGNormal saline
1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.
Sponsors
Robert Hickey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine Injections Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side.
Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. | 50 |
| Normal Saline Injections Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side.
Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. | 50 |
| Observation Observation for 30 minutes. | 50 |
| Total | 150 |
Baseline characteristics
| Characteristic | Normal Saline Injections | Observation | Ropivacaine Injections | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 50 Participants | 50 Participants | 150 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 | 14 years STANDARD_DEVIATION 2 | 14 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 50 participants | 50 participants | 50 participants | 150 participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 38 Participants | 114 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 16 / 50 | 11 / 50 | 12 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine Injections | The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. | 16 Participants |
| Normal Saline Injections | The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. | 14 Participants |
| Observation | The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. | 2 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine Injections | Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision | 10 Participants |
| Normal Saline Injections | Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision | 10 Participants |
| Observation | Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision | 12 Participants |
Secondary
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine Injections | Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study | 7 Participants |
| Normal Saline Injections | Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study | 7 Participants |
| Observation | Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study | 4 Participants |