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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. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Placebo | Placebo Comparator | Control patients will receive intranasal saline |
|
| Nasal Midazolam Only | Active Comparator | Patients will receive 0.2 mg/kg of intranasal midazolam |
|
| Midazolam Plus Xylocaine | Active Comparator | Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | midazolam 0.2 mg/kg given intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement
| 25 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge | The time (in minutes) from release from the operating room to discharge home | approximately 3 hours |
| Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home |
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 will receive intranasal saline saline placebo: intranasal saline given as placebo |
| FG001 | Nasal Midazolam Only | Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally |
| FG002 | Midazolam Plus Xylocaine | Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline Placebo | Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo |
| BG001 | Nasal Midazolam Only | Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally |
| 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 | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement
| Posted | Count of Participants | Participants | 25 minutes |
|
During patient recovery - from time of entry into the recovery room until discharge (~3 hours)
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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 will receive intranasal saline saline placebo: intranasal saline given as placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Ullman | Bassett Healthcare | 585-750-7510 | doccfi@hotmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2014 | Jul 8, 2019 | Prot_000.pdf |
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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 | intransal xylocaine given in conjunction with intranasal midazolam |
|
| saline placebo | Drug | intranasal saline given as placebo |
|
| 20 minutes |
Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration.
| approximately 3 hours |
| Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment) | Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse. | 1 minute |
| Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet) | Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse. | 5minutes |
| BG002 | Midazolam Plus Xylocaine | Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally |
| OG002 | Midazolam Plus Xylocaine | Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam |
|
|
|
| Secondary | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia
| Posted | Count of Participants | Participants | 20 minutes |
|
|
|
|
| Other Pre-specified | Time to Discharge | The time (in minutes) from release from the operating room to discharge home | Posted | Median | Inter-Quartile Range | minutes | approximately 3 hours |
|
|
|
|
| Other Pre-specified | Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home | Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration. | Posted | Count of Participants | Participants | approximately 3 hours |
|
|
|
| Other Pre-specified | Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment) | Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse. | Posted | Median | Inter-Quartile Range | cm VAS | 1 minute |
|
|
|
|
| Other Pre-specified | Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet) | Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse. | Posted | Median | Inter-Quartile Range | cm VAS | 5minutes |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Nasal Midazolam Only | Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Midazolam Plus Xylocaine | Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam | 0 | 14 | 0 | 14 | 0 | 14 |
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| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Male |
|
| Calm |
|
| Drowsy |
|
| Asleep |
|