Trial Outcomes & Findings for Combined Ketamine/Propofol for Emergency Department Procedural Sedation (NCT NCT01126957)

Results Overview

1. Endotracheal carbon dioxide (ETCO2) rise \> 5mm/hg 2. Arterial oxygen saturation (SaO2) \<90% 3. Respiratory rate (RR) \< 8 br/min 4. Apnea \> 15 sec 5. airway manipulation

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

107 participants

Primary outcome timeframe

Baseline and throughout procedure

Results posted on

2023-04-24

Participant Flow

107 participants were consented for the study. 103 completed.

We know that 107 participants had enrolled as of February 2008 and that 4 were terminated by the PI as not eligible. 103 were noted to have completed. However, the PI left the institution without making available any results or analyzed data.

Participant milestones

Participant milestones
Measure	Ketamine or Placebo Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine or placebo infusion, followed by propofol to maintain sedation. Ketamine: Ketamine was given as a 0.5mg / Kg bolus. Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo Propofol: Propofol given to both arms to maintain sedation throughout procedure.
Overall Study STARTED	103
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Ketamine/Propofol for Emergency Department Procedural Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine or Placebo n=107 Participants Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation. Ketamine: Ketamine was given as a 0.5mg / Kg bolus. Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo Propofol: Propofol given to both arms to maintain sedation throughout procedure.
Age, Customized Age >1 year	107 Participants n=5 Participants
Sex/Gender, Customized Male and Female	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and throughout procedure

Population: 103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.

1. Endotracheal carbon dioxide (ETCO2) rise \> 5mm/hg 2. Arterial oxygen saturation (SaO2) \<90% 3. Respiratory rate (RR) \< 8 br/min 4. Apnea \> 15 sec 5. airway manipulation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 20 minutes

Population: 103 participants completed the study. Data were collected but were not analyzed prior to the investigator leaving the institution, and neither did he make the data available for analysis.

Score of 1 to 5 with 5 being completely satisfied and 1 being not satisfied at all was recorded by both the monitoring nurse and the physician performing the procedural sedation

Outcome measures

Outcome data not reported

Adverse Events

Ketamine or Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Henry

University of Missouri-Columbia

Phone: 573/884-2582

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place