Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study

NCT02145169 | Completed Results DMC

• 1 other identifier: HN4507FBD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To describe the safety and efficacy of nitrous oxide during ketamine administration for the prevention of emergence reaction during Emergency Department procedural sedation and analgesia in adults. Drugs such as fentanyl, midazolam, and propofol are widely used in emergency departments for procedural sedation and analgesia because they have a rapid onset and short duration of action. Unfortunately, all of these agents may cause respiratory depression, particularly when combined with other sedative agents, administered in large doses, or given to patients with underlying respiratory diseases. Nitrous oxide use during ketamine administration may be an ideal combination for the prevention of emergence reaction in adults sedated in the ED. Like ketamine, nitrous oxide has an excellent cardio-respiratory profile as well as some analgesic and anxiolytic qualities. The anxiety and pain surrounding procedural sedation is not limited to the procedure itself, but the elapsed time from the time the patient enters the ED to the time spent in preparation for the procedure can be significant and lead to increased anxiety, which may exacerbate emergence reactions in adults. Using nitrous oxide before ketamine administration may mitigate this. While midazolam has shown efficacy in reducing emergence reactions in adults sedated with ketamine, the investigators believe that inhaled nitrous oxide may be equivalent to midazolam, with a better cardio-respiratory profile.

Conditions

Emergence Reaction; Procedural Sedation

Keywords

procedural sedation; emergence reaction; nitrous oxide; ketamine

Outcome Measures

Primary Outcomes (1)

• Emergence Reaction

  Presence or absence of emergence reaction

  At primary ED visit when the patient is undergoing the intervention

Secondary Outcomes (12)

• Physiologic Measure

  At primary ED visit when the patient is undergoing the intervention

• Physiologic Measure

  At primary ED visit when the patient is undergoing the intervention

• Vitals

  At primary ED visit when the patient is undergoing the intervention

• Physician Interventions

  At primary ED visit when the patient is undergoing the intervention

• Level of Sedation

  At primary ED visit when the patient is undergoing the intervention

Study Arms (1)

Nitrous Oxide arm

EXPERIMENTAL

Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask

Drug: Inhaled Nitrous Oxide

Interventions

Inhaled Nitrous Oxide DRUG

Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide

Nitrous Oxide arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Limitations and Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Results Point of Contact

• Title: Kamran Mohiuddin. Director Clinical Research Emergency Department
• Organization: Albert Einstein Medical Center

MOHIUDDK@EISNTEIN.EDU

2154562313

Study Officials

• Paul Dominici, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2014
• First Posted: May 22, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)