Trial Outcomes & Findings for Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study (NCT NCT02145169)
NCT ID: NCT02145169
Last Updated: 2020-03-19
Results Overview
Presence or absence of emergence reaction
COMPLETED
NA
20 participants
At primary ED visit when the patient is undergoing the intervention
2020-03-19
Participant Flow
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Participant milestones
| Measure |
Nitrous Oxide Arm
Patients will receive a 50/50 mixture of Oxygen and Nitrous oxide via non breather mask
Inhaled Nitrous Oxide: Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide
|
|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Presence or absence of emergence reaction
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
ETCO2 measured q 5 seconds
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
SpO2 measured q 5 seconds
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
heart rate, respiratory rate, peripheral SaO2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
verbal or physical stimulation, airway repositioning, additional oxygen, positive pressure ventilation, endotracheal intubation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Ramsay sedation score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Patient recall of procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Total Ketamine dose
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visit when the patient is undergoing the interventionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Total elapsed time of nitrous use
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At procedure completionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Physician procedure satisfaction survey responses
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At procedure completionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Patient procedure satisfaction survey responses
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At procedure completionPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Nurse procedure satisfaction survey responses
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At primary ED visitPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Length of ED stay
Outcome measures
Outcome data not reported
Adverse Events
Nitrous Oxide Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamran Mohiuddin. Director Clinical Research Emergency Department
Albert Einstein Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place