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The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.
Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline placebo | Placebo Comparator | saline placebo |
|
| Nasal Midazolam only | Active Comparator | Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam |
|
| Midazolam and Xylocaine | Active Comparator | Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Study participants will be randomly assigned to one of three treatment groups:
|
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Scale Score | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. | 10 minutes post-sedation |
| Sedation Scale Score | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. | 15 minutes post-sedation |
| Time From Administration to Discharge | Minutes from administration to discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Observed Behavioral Distress Score | Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible). | 1 minute post-administration |
| RN Observed Behavioral Distress Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| david Ullman, MD | Bassett Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bassett Healthcare Network | Cooperstown | New York | 13326 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline Placebo | Control patients received intranasal saline. |
| FG001 | Nasal Midazolam Only | Patients received 0.2 mg/kg of intranasal midazolam |
| FG002 | Midazolam Plus Xylocaine | Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
It was determined that a minimum of 15 patients (5 in each group) were necessary for baseline statistical analysis of this pilot study, to be used in performing a formal power analysis and sample size calculation. However, limitations in the number of providers and eligible patients during the two-year study period prevented further recruitment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Placebo | Control patients received intranasal saline. |
| BG001 | Nasal Midazolam Only | Patients received 0.2 mg/kg of intranasal midazolam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Sedation Scale Score | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. | participants with available data at this time point | Posted | Number | participants | 10 minutes post-sedation |
|
During hospital stay.
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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 | Saline Placebo | Control patients received intranasal saline. |
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Limitations in the number of providers and eligible patients during the two-year study period.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David A. Ullman, MD, Senior Attending Anesthesiologist | Bassett Healthcare Network | 607-547-3153 | david.ullman@bassett.org |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
|
| xylocaine | Drug | Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. |
|
| saline placebo | Drug | Placebo - Control patients will receive intranasal saline. |
|
Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible). |
| 1 minute post-administration |
| Verbal Complaint | Recorded by the administering RN at the time of administration. | At time of administration |
| Verbal Complaints | Recorded by the administering RN at one minute post-administration | 1 minute post-administration |
| BG002 | Midazolam Plus Xylocaine | Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiologists Physical Status Class | ASA Class 1: A healthy patient, ASA Class 2: A patient with mild systemic disease | Number | participants |
|
Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
|
|
|
| Primary | Sedation Scale Score | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. | participants with available data at this time point | Posted | Number | participants | 15 minutes post-sedation |
|
|
|
|
| Primary | Time From Administration to Discharge | Posted | Mean | Standard Deviation | minutes | Minutes from administration to discharge |
|
|
|
|
| Secondary | Parental Observed Behavioral Distress Score | Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible). | Posted | Mean | Standard Deviation | units on a scale | 1 minute post-administration |
|
|
|
|
| Secondary | RN Observed Behavioral Distress Score | Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible). | Posted | Mean | Standard Deviation | units on a scale | 1 minute post-administration |
|
|
|
|
| Secondary | Verbal Complaint | Recorded by the administering RN at the time of administration. | Posted | Number | participants | At time of administration |
|
|
|
|
| Secondary | Verbal Complaints | Recorded by the administering RN at one minute post-administration | Posted | Number | participants | 1 minute post-administration |
|
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Nasal Midazolam Only | Patients received 0.2 mg/kg of intranasal midazolam | 0 | 5 | 0 | 5 |
| EG002 | Midazolam Plus Xylocaine | Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam. | 0 | 5 | 0 | 5 |
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| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Title | Measurements |
|---|---|
|
| Calm |
|
| Drowsy |
|
| Asleep |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|