A Phase 4 interventional study of Nitrous Oxide and Midazolam in Conscious Sedation, Simple Lacerations Less Than 4 cm and Lumbar Punctures, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by University of Colorado, Denver · Phase 4, Interventional, and Other
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.
133 studies on the registry are indexed under Lacerations; 29 are open to participants now.
This study's enrollment of 63 is below the median of 79 across 106 interventional studies indexed under Lacerations.
Browse Lacerations studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients requiring anxiolysis and mild sedation for minor procedures
Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam.
Exclusion Criteria:
Closed space situations such as:
Patients with significant co-morbidities:
Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method.
Drug: Nitrous Oxide
Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'.
Drug: Midazolam
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%.
Also known as: N2O
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.
Also known as: Versed
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.
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
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
| Milestone | Nitrous Oxide | Intranasal Midazolam |
|---|---|---|
| Started | 19 | 41 |
| Completed | 19 | 41 |
| Not completed | 0 | 0 |
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.
| minutes | Nitrous Oxide | Intranasal Midazolam |
|---|---|---|
| Time from intranasal midazolam or nitrous oxide administration to time of discharge readiness | 24.5 (15.5 to 33.5) | 18.5 (16 to 34) |
| Time from anxiolytic/sedative given to time of procedure completion | 9 (3 to 19) | 10 (6 to 16) |
| Total time for recovery | 15.5 (12.5 to 17.5) | 8.5 (7 to 18) |
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".
| score on a scale | Nitrous Oxide | Intranasal Midazolam |
|---|---|---|
| Parent/Patient | 5 (5 to 5) | 5 (4 to 5) |
| Provider | 5 (4 to 5) | 4.5 (4 to 5) |
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.
| Adverse Events | Nitrous Oxide | Intranasal Midazolam |
|---|---|---|
| hypoxia | 0 | 3 |
| need for administration of reversal agent | 0 | 0 |
| nausea, vomiting | 0 | 0 |
| paradoxical reaction | 0 | 1 |
| airway obstruction | 0 | 0 |
| laryngospasm | 0 | 0 |
| inadequate sedation | 0 | 0 |
| allergic reaction | 0 | 0 |
| cardiac arrest | 0 | 0 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitrous Oxide | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Intranasal Midazolam | 0/41 (0%) | 0/41 (0%) | 4/41 (9.8%) |
| Event | Nitrous Oxide | Intranasal Midazolam |
|---|---|---|
| hypoxiaRespiratory, thoracic and mediastinal disorders | 0/19 | 3/41 |
| paradoxical reactionNervous system disorders | 0/19 | 1/41 |
| Age, Categorical(Participants) | Nitrous Oxide | Intranasal Midazolam | Total |
|---|---|---|---|
| <=18 years | 19 | 41 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Nitrous Oxide | Intranasal Midazolam | Total |
|---|---|---|---|
| Female | 12 | 13 | 25 |
| Male | 7 | 28 | 35 |
| Race and Ethnicity Not Collected(Participants) | Nitrous Oxide | Intranasal Midazolam | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Nitrous Oxide | Intranasal Midazolam | Total |
|---|---|---|---|
| United States | 19 | 41 | 60 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Colorado, Denver