Sedation
Conditions
Brief summary
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
Interventions
DRUGMidazolam
midazolam 0.2 mg/kg given intranasally
DRUGxylocaine
intransal xylocaine given in conjunction with intranasal midazolam
DRUGsaline placebo
intranasal saline given as placebo
Sponsors
Jennifer Victory, RN, CCRC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 7 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia 2. American Society of Anesthesiologists (ASA) Class 1 or 2 3. Parent willing and able to provide written informed consent 4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)
Exclusion criteria
1. ASA Class 3 or greater 2. History of allergy to midazolam or xylocaine 3. Presence of acute respiratory infection at time of surgery 4. Parent unwilling or unable to provide informed consent 5. Parent unwilling or unable to complete the OBD VAS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | 25 minutes | Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1\. Agitated: Previous criteria and/or refuses mask. (worst score) * 2\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3\. Calm: Previous criteria and accepts mask. * 4\. Drowsy: Previous criteria and accepts mask. * 5\. Asleep: Previous criteria and accepts mask. (best score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | 20 minutes | Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia * 1\. Agitated: Patient clinging to parents and/or crying (worst score) * 2\. Alert: Patient is aware but not clinging to parent, may whimper but not cry. * 3\. Calm: Sitting or lying comfortably with spontaneous eye opening. * 4\. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation. * 5\. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge | approximately 3 hours | The time (in minutes) from release from the operating room to discharge home |
| Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home | approximately 3 hours | Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration. |
| Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment) | 1 minute | Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse. |
| Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet) | 5minutes | Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Placebo Control patients will receive intranasal saline
saline placebo: intranasal saline given as placebo | 14 |
| Nasal Midazolam Only Patients will receive 0.2 mg/kg of intranasal midazolam
Midazolam: midazolam 0.2 mg/kg given intranasally | 14 |
| 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 | 14 |
| Total | 42 |
Baseline characteristics
| Characteristic | Nasal Midazolam Only | Midazolam Plus Xylocaine | Total | Saline Placebo |
|---|---|---|---|---|
| Age, Continuous | 3.1 years STANDARD_DEVIATION 1.5 | 2.5 years STANDARD_DEVIATION 1.7 | 2.7 years STANDARD_DEVIATION 1.6 | 2.4 years STANDARD_DEVIATION 1.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 14 participants | 14 participants | 42 participants | 14 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 22 Participants | 7 Participants |
| Sex: Female, Male Male | 9 Participants | 4 Participants | 20 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
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 * 1\. Agitated: Previous criteria and/or refuses mask. (worst score) * 2\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3\. Calm: Previous criteria and accepts mask. * 4\. Drowsy: Previous criteria and accepts mask. * 5\. Asleep: Previous criteria and accepts mask. (best score)
Time frame: 25 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Drowsy | 0 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Calm | 2 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Agitated | 11 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Alert | 1 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Asleep | 0 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Calm | 10 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Agitated | 3 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Alert | 1 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Drowsy | 0 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Asleep | 0 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Asleep | 0 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Drowsy | 1 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Agitated | 6 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Calm | 4 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement | Alert | 3 Participants |
p-value: 0.39Chi-squared
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 * 1\. Agitated: Patient clinging to parents and/or crying (worst score) * 2\. Alert: Patient is aware but not clinging to parent, may whimper but not cry. * 3\. Calm: Sitting or lying comfortably with spontaneous eye opening. * 4\. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation. * 5\. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)
Time frame: 20 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Drowsy | 0 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Calm | 8 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Agitated | 5 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Alert | 1 Participants |
| Saline Placebo | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Asleep | 0 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Calm | 9 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Agitated | 1 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Alert | 3 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Drowsy | 1 Participants |
| Nasal Midazolam Only | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Asleep | 0 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Asleep | 0 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Drowsy | 1 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Agitated | 1 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Calm | 9 Participants |
| Midazolam Plus Xylocaine | Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room | Alert | 3 Participants |
p-value: 0.39Chi-squared
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.
Time frame: approximately 3 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saline Placebo | Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home | 0 Participants |
| Nasal Midazolam Only | Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home | 0 Participants |
| Midazolam Plus Xylocaine | Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home | 0 Participants |
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.
Time frame: 5minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet) | 0 cm VAS |
| Nasal Midazolam Only | Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet) | 0.02 cm VAS |
| Midazolam Plus Xylocaine | Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet) | 0 cm VAS |
p-value: 0.08Kruskal-Wallis
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.
Time frame: 1 minute
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment) | 0.02 cm VAS |
| Nasal Midazolam Only | Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment) | 0.3 cm VAS |
| Midazolam Plus Xylocaine | Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment) | 0.4 cm VAS |
p-value: 0.01Kruskal-Wallis
Other Pre-specified
Time to Discharge
The time (in minutes) from release from the operating room to discharge home
Time frame: approximately 3 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Saline Placebo | Time to Discharge | 35 minutes |
| Nasal Midazolam Only | Time to Discharge | 39.5 minutes |
| Midazolam Plus Xylocaine | Time to Discharge | 35.5 minutes |
p-value: 0.88Kruskal-Wallis