Children Requiring Sedation to Facilitate Laceration Repair
Conditions
Keywords
Sedation, Laceration repair, Children, Intranasal, Midazolam
Brief summary
The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal volume of administration by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.
Detailed description
The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs are not concentrated enough so that small volumes can be consistently given, so as a result, sometimes a very large amount of medication is administered intranasally. When the amount is too large, most of the medication either runs back out the nose, or down the back of the nose and throat and is swallowed, instead of being absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal effectiveness.
Interventions
Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* 1 to 7 years of age, inclusive. * Require intranasal midazolam for minimal sedation to facilitate laceration repair.
Exclusion criteria
* Weight less than 10 kg. * Known allergy to midazolam. * Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared * Inability to speak English or Spanish * Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inflammatory bowel disease). * Foster children or wards.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation | 20 minutes | This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observational Scale of Behavioral Distress - Revised | 60 minutes | The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase. |
| Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration | 60 minutes | This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 200 mcL VOA Intranasal midazolam administered in 200 mcL VOA
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD). | 32 |
| 500 mcL VOA Intranasal midazolam administered in 500 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD). | 33 |
| 1000 mcL VOA Intranasal midazolam administered in 1000 mcL VOA.
Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD). | 31 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | 200 mcL VOA | 500 mcL VOA | 1000 mcL VOA | Total |
|---|---|---|---|---|
| Age, Continuous | 3 years | 2.7 years | 2.7 years | 2.9 years |
| Race/Ethnicity, Customized Hispanic | 22 participants | 25 participants | 25 participants | 72 participants |
| Race/Ethnicity, Customized Non-Hispanic, Black | 3 participants | 2 participants | 1 participants | 6 participants |
| Race/Ethnicity, Customized Non-Hispanic, Other | 1 participants | 1 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Non-Hispanic, White | 6 participants | 5 participants | 5 participants | 16 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 12 Participants | 32 Participants |
| Sex: Female, Male Male | 20 Participants | 25 Participants | 19 Participants | 64 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 / 32 | 4 / 33 | 1 / 31 |
| serious Total, serious adverse events | 0 / 32 | 0 / 33 | 0 / 31 |
Outcome results
Primary
Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation
This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.
Time frame: 20 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 200 mcL VOA | Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation | 4.7 minutes |
| 500 mcL VOA | Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation | 4.3 minutes |
| 1000 mcL VOA | Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation | 5.2 minutes |
Secondary
Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration
This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 200 mcL VOA | Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration | 13 participants |
| 500 mcL VOA | Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration | 30 participants |
| 1000 mcL VOA | Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration | 30 participants |
Secondary
Observational Scale of Behavioral Distress - Revised
The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.
Time frame: 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 200 mcL VOA | Observational Scale of Behavioral Distress - Revised | 6.06 units |
| 500 mcL VOA | Observational Scale of Behavioral Distress - Revised | 7.90 units |
| 1000 mcL VOA | Observational Scale of Behavioral Distress - Revised | 8.56 units |