Sedation, Conscious
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMidazolam
Study participants will be randomly assigned to one of three treatment groups: * Group 1 - Placebo - Control patients will receive intranasal saline. * Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam. * Group 3 - 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.
DRUGxylocaine
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.
DRUGsaline placebo
Placebo - Control patients will receive intranasal saline.
Sponsors
Bassett Healthcare
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 otolaryngology (ENT) 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 OBD 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 |
|---|---|---|
| Sedation Scale Score | 10 minutes post-sedation | Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep. |
| Time From Administration to Discharge | Minutes from administration to discharge | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Observed Behavioral Distress Score | 1 minute post-administration | 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). |
| RN Observed Behavioral Distress Score | 1 minute post-administration | 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). |
| Verbal Complaint | At time of administration | Recorded by the administering RN at the time of administration. |
| Verbal Complaints | 1 minute post-administration | Recorded by the administering RN at one minute post-administration |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Placebo Control patients received intranasal saline. | 5 |
| Nasal Midazolam Only Patients received 0.2 mg/kg of intranasal midazolam | 5 |
| 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. | 5 |
| Total | 15 |
Baseline characteristics
| Characteristic | Saline Placebo | Nasal Midazolam Only | Midazolam Plus Xylocaine | Total |
|---|---|---|---|---|
| Age, Continuous | 3.2 years STANDARD_DEVIATION 2.2 | 4.0 years STANDARD_DEVIATION 1.2 | 4.0 years STANDARD_DEVIATION 2 | 3.7 years STANDARD_DEVIATION 1.8 |
| American Society of Anesthesiologists Physical Status Class ASA Class 1 | 1 participants | 2 participants | 2 participants | 5 participants |
| American Society of Anesthesiologists Physical Status Class ASA Class 2 | 4 participants | 3 participants | 3 participants | 10 participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Sedation Scale Score
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time frame: 10 minutes post-sedation
Population: participants with available data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saline Placebo | Sedation Scale Score | Agitated | 0 participants |
| Saline Placebo | Sedation Scale Score | Calm | 3 participants |
| Saline Placebo | Sedation Scale Score | Drowsy | 0 participants |
| Saline Placebo | Sedation Scale Score | Alert | 1 participants |
| Saline Placebo | Sedation Scale Score | Asleep | 0 participants |
| Nasal Midazolam Only | Sedation Scale Score | Alert | 2 participants |
| Nasal Midazolam Only | Sedation Scale Score | Asleep | 0 participants |
| Nasal Midazolam Only | Sedation Scale Score | Calm | 2 participants |
| Nasal Midazolam Only | Sedation Scale Score | Agitated | 0 participants |
| Nasal Midazolam Only | Sedation Scale Score | Drowsy | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Asleep | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Calm | 3 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Alert | 2 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Agitated | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Drowsy | 0 participants |
p-value: 0.99Chi-squared
Primary
Sedation Scale Score
Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.
Time frame: 15 minutes post-sedation
Population: participants with available data at this time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saline Placebo | Sedation Scale Score | Drowsy | 0 participants |
| Saline Placebo | Sedation Scale Score | Calm | 3 participants |
| Saline Placebo | Sedation Scale Score | Agitated | 0 participants |
| Saline Placebo | Sedation Scale Score | Alert | 1 participants |
| Saline Placebo | Sedation Scale Score | Asleep | 0 participants |
| Nasal Midazolam Only | Sedation Scale Score | Calm | 2 participants |
| Nasal Midazolam Only | Sedation Scale Score | Agitated | 0 participants |
| Nasal Midazolam Only | Sedation Scale Score | Alert | 1 participants |
| Nasal Midazolam Only | Sedation Scale Score | Drowsy | 0 participants |
| Nasal Midazolam Only | Sedation Scale Score | Asleep | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Asleep | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Drowsy | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Agitated | 0 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Calm | 2 participants |
| Midazolam Plus Xylocaine | Sedation Scale Score | Alert | 1 participants |
p-value: 0.99Chi-squared
Primary
Time From Administration to Discharge
Time frame: Minutes from administration to discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline Placebo | Time From Administration to Discharge | 87.0 minutes | Standard Deviation 21.9 |
| Nasal Midazolam Only | Time From Administration to Discharge | 74.2 minutes | Standard Deviation 9.6 |
| Midazolam Plus Xylocaine | Time From Administration to Discharge | 97.0 minutes | Standard Deviation 18.9 |
p-value: 0.26Kruskal-Wallis
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).
Time frame: 1 minute post-administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline Placebo | Parental Observed Behavioral Distress Score | 0.08 units on a scale | Standard Deviation 0.2 |
| Nasal Midazolam Only | Parental Observed Behavioral Distress Score | 3.10 units on a scale | Standard Deviation 2.4 |
| Midazolam Plus Xylocaine | Parental Observed Behavioral Distress Score | 1.96 units on a scale | Standard Deviation 1.5 |
p-value: 0.02Kruskal-Wallis
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).
Time frame: 1 minute post-administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saline Placebo | RN Observed Behavioral Distress Score | 0.1 units on a scale | Standard Deviation 0.2 |
| Nasal Midazolam Only | RN Observed Behavioral Distress Score | 2.4 units on a scale | Standard Deviation 3 |
| Midazolam Plus Xylocaine | RN Observed Behavioral Distress Score | 1.9 units on a scale | Standard Deviation 1.7 |
p-value: 0.04Kruskal-Wallis
Secondary
Verbal Complaint
Recorded by the administering RN at the time of administration.
Time frame: At time of administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saline Placebo | Verbal Complaint | No Complaint | 3 participants |
| Saline Placebo | Verbal Complaint | Complaint Reported | 2 participants |
| Nasal Midazolam Only | Verbal Complaint | Complaint Reported | 4 participants |
| Nasal Midazolam Only | Verbal Complaint | No Complaint | 1 participants |
| Midazolam Plus Xylocaine | Verbal Complaint | Complaint Reported | 3 participants |
| Midazolam Plus Xylocaine | Verbal Complaint | No Complaint | 2 participants |
p-value: 0.73Chi-squared
Secondary
Verbal Complaints
Recorded by the administering RN at one minute post-administration
Time frame: 1 minute post-administration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Saline Placebo | Verbal Complaints | No Complaint | 5 participants |
| Saline Placebo | Verbal Complaints | Complaint Reported | 0 participants |
| Nasal Midazolam Only | Verbal Complaints | No Complaint | 3 participants |
| Nasal Midazolam Only | Verbal Complaints | Complaint Reported | 2 participants |
| Midazolam Plus Xylocaine | Verbal Complaints | No Complaint | 4 participants |
| Midazolam Plus Xylocaine | Verbal Complaints | Complaint Reported | 1 participants |
p-value: 0.73Chi-squared