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Objective: To determine if lower paracervical intramuscular ropivacaine injection is an effective treatment for pediatric headache in an emergency department setting.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine Injections | Experimental | Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. |
|
| Normal Saline Injections | Placebo Comparator | Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. |
|
| Observation | No Intervention | Observation for 30 minutes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. | 30 minutes |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Sieminski, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Observation | Observation for 30 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Normal Saline Injections |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department. | Posted | Count of Participants | Participants | 30 minutes |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain at injection site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Hickey | Children's Hospital of Pittsburgh | 412 692 7692 | robert.hickey@chp.edu |
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| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal saline | Drug | 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1. |
|
| 72 hours |
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. |
| BG002 | Observation | Observation for 30 minutes. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Observation |
Observation for 30 minutes. |
|
|
| Secondary | Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision | Posted | Count of Participants | Participants | 3 hours |
|
|
|
| Secondary | Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study | Posted | Count of Participants | Participants | 72 hours |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 16 |
| 50 |
| EG001 | 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. | 0 | 50 | 0 | 50 | 11 | 50 |
| EG002 | Observation | Observation for 30 minutes. | 0 | 50 | 0 | 50 | 12 | 50 |
| neck pain at 3 days | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| neck pain at 1 month | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |