Conscious Sedation, Lumbar Punctures, Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement, Simple Lacerations Less Than 4 cm
Conditions
Brief summary
The objective of this project is to compare the sedative effects of intranasal midazolam versus inhaled nitrous oxide (N2O) for minor procedures in the pediatric emergency department. The primary outcome will be length of stay (LOS) in the emergency department (ED) stay for minor procedures. Secondarily the investigators will compare patient/family and provider satisfaction while using either intranasal midazolam or N2O for minimal sedation. The investigators hypothesize that the total length of stay for children undergoing minor procedures in the ED will be lower for N2O, as compared to intranasal midazolam. The investigators also hypothesize that patient/family and provider satisfaction will be higher with N2O and adverse effects will not differ between N2O and intranasal midazolam. Patients will receive either intranasal midazolam or N2O for minor procedures. Following the enrollment period, data will be analyzed and the two will be compared. Total length of stay, patient/family and provider satisfaction will be studied.
Interventions
DRUGNitrous Oxide
Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%.
DRUGMidazolam
Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Patients ≥2 years of age and \<18 years of age, and 2. Parent/legal guardian age ≥18 years of age to \<80 years of age 3. Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System level 1, 2, and 3 4. Patients requiring anxiolysis and mild sedation for minor procedures 1. Minor procedures will include simple lacerations less than 4 cm 2. Lumbar punctures 3. Minor incision 4. Drainage of abscesses that do not require extensive debridement 5. Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam. 1. Nitrous oxide up to 70% nitrous concentration will be allowed 2. Intranasal Midazolam 0.4mg/kg with a max dose of 10mg
Exclusion criteria
1. Nasal injury, nasal obstruction or significant congestion 2. Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing 3. Allergy to benzodiazepines 4. Benzodiazepine dosing for any reason 24 hours prior to procedure 5. Excessive Epistaxis 6. Facial or nasal deformity 7. Copious mucous 8. Recent (less than 1 week) tympanic membrane graft or middle ear surgery 9. Recent bleomycin therapy 10. Patients known to be pregnant at time of enrollment 11. Patients with severe behavior problems, personality disorders or other mind-altering conditions as determined by administering provider. 12. Closed space situations such as: 1. pneumothorax, 2. air embolus, 3. pneumocephalus, or 4. craniotomy in the last 3 weeks, 5. intraocular surgery with retained gas, 6. pulmonary bullae, 7. severe emphysema, or 8. bowel obstruction. 13. Patients with significant co-morbidities: 1. severe pulmonary disease, 2. cardiac disease, 3. hematologic diseases associated with B12 deficiency, 4. sickle cell disease. 14. Patients with acute otitis media and/or sinusitis 15. History of paradoxical reaction to nitrous oxide 16. Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients 17. Co-administration of additional sedation or analgesic medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours. | The total length of Emergency Department (ED) stay will be defined as time from intranasal midazolam or nitrous oxide administration to time of discharge readiness, collected by the research assistants. Additional time periods measured will include: time from anxiolytic/sedative given to time of procedure completion, and total time for recovery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative. | Time of discharge, Approximately 2 hours | Patient/parent satisfaction will be assessed for all patients; child satisfaction will be assessed for patients over 12 years of age. Satisfaction will be measured on a scale of 1 to 5 (1 being not satisfied and 5 being very satisfied). Specifically, parents (and children when applicable) will be asked how satisfied with the means of sedation were you for the procedure performed. Research assistants will then ask the ED providers on a scale of 1 to 5 (1 being not satisfied and 5 being very satisfied) how satisfied with the means of sedation were you for the procedure performed. |
| Adverse Events. | Time of discharge, Approximately 2 hours | Number of adverse events observed. Adverse events will be classified and defined as hypoxia, need for administration of reversal agent, nausea, vomiting, paradoxical reaction, airway obstruction, laryngospasm, inadequate sedation, allergic reaction, and cardiac arrest. |
Countries
United States
Participant flow
Pre-assignment details
Three patients were excluded prior to randomization (two withdrawals, one screen failure).
Participants by arm
| Arm | Count |
|---|---|
| Nitrous Oxide Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.
Nitrous Oxide: Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%. | 19 |
| Intranasal Midazolam Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.
Midazolam: Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures. | 41 |
| Total | 60 |
Baseline characteristics
| Characteristic | Intranasal Midazolam | Total | Nitrous Oxide |
|---|---|---|---|
| Age, Categorical <=18 years | 41 Participants | 60 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 41 participants | 60 participants | 19 participants |
| Sex: Female, Male Female | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 28 Participants | 35 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 41 |
| other Total, other adverse events | 0 / 19 | 4 / 41 |
| serious Total, serious adverse events | 0 / 19 | 0 / 41 |
Outcome results
Primary
ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration
The total length of Emergency Department (ED) stay will be defined as time from intranasal midazolam or nitrous oxide administration to time of discharge readiness, collected by the research assistants. Additional time periods measured will include: time from anxiolytic/sedative given to time of procedure completion, and total time for recovery.
Time frame: From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nitrous Oxide | ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | Time from intranasal midazolam or nitrous oxide administration to time of discharge readiness | 24.5 minutes |
| Nitrous Oxide | ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | Time from anxiolytic/sedative given to time of procedure completion | 9 minutes |
| Nitrous Oxide | ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | Total time for recovery | 15.5 minutes |
| Intranasal Midazolam | ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | Time from intranasal midazolam or nitrous oxide administration to time of discharge readiness | 18.5 minutes |
| Intranasal Midazolam | ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | Time from anxiolytic/sedative given to time of procedure completion | 10 minutes |
| Intranasal Midazolam | ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration | Total time for recovery | 8.5 minutes |
Secondary
Adverse Events.
Number of adverse events observed. Adverse events will be classified and defined as hypoxia, need for administration of reversal agent, nausea, vomiting, paradoxical reaction, airway obstruction, laryngospasm, inadequate sedation, allergic reaction, and cardiac arrest.
Time frame: Time of discharge, Approximately 2 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nitrous Oxide | Adverse Events. | need for administration of reversal agent | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | laryngospasm | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | paradoxical reaction | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | inadequate sedation | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | nausea, vomiting | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | allergic reaction | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | airway obstruction | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | cardiac arrest | 0 Adverse Events |
| Nitrous Oxide | Adverse Events. | hypoxia | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | cardiac arrest | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | hypoxia | 3 Adverse Events |
| Intranasal Midazolam | Adverse Events. | need for administration of reversal agent | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | nausea, vomiting | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | paradoxical reaction | 1 Adverse Events |
| Intranasal Midazolam | Adverse Events. | airway obstruction | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | laryngospasm | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | inadequate sedation | 0 Adverse Events |
| Intranasal Midazolam | Adverse Events. | allergic reaction | 0 Adverse Events |
Secondary
Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative.
Patient/parent satisfaction will be assessed for all patients; child satisfaction will be assessed for patients over 12 years of age. Satisfaction will be measured on a scale of 1 to 5 (1 being not satisfied and 5 being very satisfied). Specifically, parents (and children when applicable) will be asked how satisfied with the means of sedation were you for the procedure performed. Research assistants will then ask the ED providers on a scale of 1 to 5 (1 being not satisfied and 5 being very satisfied) how satisfied with the means of sedation were you for the procedure performed.
Time frame: Time of discharge, Approximately 2 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nitrous Oxide | Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative. | Parent/Patient | 5 score on a scale |
| Nitrous Oxide | Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative. | Provider | 5 score on a scale |
| Intranasal Midazolam | Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative. | Parent/Patient | 5 score on a scale |
| Intranasal Midazolam | Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative. | Provider | 4.5 score on a scale |