Conscious SedationPhase 4NCT03085563
A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
A Phase 4 study testing Nitrous Oxide and Midazolam in people with Conscious Sedation and Simple Lacerations Less Than 4 cm, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Conscious Sedation, Simple Lacerations Less Than 4 cm, Lumbar Punctures
- What is being tested?
- Nitrous Oxide and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 8 Nov 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients ≥2 years of age and <18 years of age, and
- Parent/legal guardian age ≥18 years of age to <80 years of age
- Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System level 1, 2, and 3
- Patients requiring anxiolysis and mild sedation for minor procedures
- Minor procedures will include simple lacerations less than 4 cm
- Lumbar punctures
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- Minor incision
- Drainage of abscesses that do not require extensive debridement
- Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam.
- Nitrous oxide up to 70% nitrous concentration will be allowed
- Intranasal Midazolam 0.4mg/kg with a max dose of 10mg
Who cannot join
- Nasal injury, nasal obstruction or significant congestion
- Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing
- Allergy to benzodiazepines
- Benzodiazepine dosing for any reason 24 hours prior to procedure
- Excessive Epistaxis
- Facial or nasal deformity
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- Copious mucous
- Recent (less than 1 week) tympanic membrane graft or middle ear surgery
- Recent bleomycin therapy
- Patients known to be pregnant at time of enrollment
- Patients with severe behavior problems, personality disorders or other mind-altering conditions as determined by administering provider.
- Closed space situations such as:
- pneumothorax,
- air embolus,
- pneumocephalus, or
- craniotomy in the last 3 weeks,
- intraocular surgery with retained gas,
- pulmonary bullae,
- severe emphysema, or
- bowel obstruction.
- Patients with significant co-morbidities:
- severe pulmonary disease,
- cardiac disease,
- hematologic diseases associated with B12 deficiency,
- sickle cell disease.
- Patients with acute otitis media and/or sinusitis
- History of paradoxical reaction to nitrous oxide
- Known Methicillin-resistant Staphylococcus aureus (MRSA+) patients
- Co-administration of additional sedation or analgesic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Conscious Sedation, Simple Lacerations Less Than 4 cm, Lumbar Punctures, Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement
- Being tested
- Nitrous Oxide, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
Also called N2O
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%.
MidazolamDrug
Also called Versed
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.
| Study group | Role | What they receive |
|---|---|---|
| Nitrous Oxide | Active comparator | Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Receives: Drug: Nitrous Oxide |
| Intranasal Midazolam | Active comparator | Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours.
Secondary outcomes (2)
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".
Measured: 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.
Measured: Time of discharge, Approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start24 May 2017
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Conscious SedationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul A Szefler, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085563
- Sponsor's protocol ID
- 16-1909
- Status last verified
- Apr 2022
- First submitted
- 21 Oct 2016
- Last updated
- 10 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intranasal Midazolam and Nitrous Oxide (N2O) Minimal Sedation for Minor Procedures in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT03085563
- Acronym / sponsor ID
- 16-1909
- Conditions
- Conscious Sedation, Simple Lacerations Less Than 4 cm, Lumbar Punctures, Minor Incision Drainage of Abscesses Not Requiring Extensive Debridement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 24 May 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Posted 10 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrous Oxide | Active comparator | Drug: Nitrous OxideNitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. |
| Intranasal Midazolam | Active comparator | Drug: MidazolamIntranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Patients ≥2 years of age and <18 years of age, and
- Parent/legal guardian age ≥18 years of age to <80 years of age
- Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System level 1, 2, and 3
- Patients requiring anxiolysis and mild sedation for minor procedures
- Must receive the standard of care dosing for either nitrous oxide or intranasal midazolam.
Key exclusion criteria (29 listed)
- Nasal injury, nasal obstruction or significant congestion
- Laceration that involves the nose and ears or come into contact with the scavenger device or nitrous oxide tubing
- Allergy to benzodiazepines
- Benzodiazepine dosing for any reason 24 hours prior to procedure
- Excessive Epistaxis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous OxideAlso: N2ONitrous 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%. | Drug | Nitrous Oxide |
| MidazolamAlso: VersedIntranasal 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. | Drug | Intranasal Midazolam |
Primary outcome
ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration
Time frame: 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.
2 secondary outcomes
Patient/Parent and Provider Satisfaction With Sedation and Anxiolytic/Sedative.
Time frame: Time of discharge, Approximately 2 hours
Adverse Events.
Time frame: Time of discharge, Approximately 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Szefler, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrous Oxide and Midazolam in people with Conscious Sedation and Simple Lacerations Less Than 4 cm, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED Length of Stay After Intranasal Midazolam or Nitrous Oxide Administration (time frame: From administration of intranasal midazolam or nitrous oxide, assessed over an estimated time of 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.