Clinical trial NCT01260662: Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
Official title: Randomized Blinded Three Arm Trial of Propofol, 1:1 Combination of Propofol and Ketamine, and 4:1 Combination of Propofol and Ketamine for Procedural Sedation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Procedural Sedation
Keywords: Deep Procedural Sedation
Propofol
Ketamine
Emergency Department
Monitoring
Capnography
Procedural Sedation in the Emergency Department
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 271
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a randomized trial of propofol versus the combination of propofol and ketamine for procedural sedation for procedures in the Emergency Department (ED). Propofol produces sedation, hypnosis, and dense amnesia, and is commonly used in the ED at Hennepin County Medical Center (HCMC) for procedural sedation. Ketamine is a dissociative anesthetic that is also frequently used in the ED in children and sometimes in adults. It has been proposed that by combining the two agents, the negative side effects of respiratory depression and hypotension associated with propofol, and the negative effects of dysphoria and vomiting associated with ketamine, can be avoided.

In the proposed study, patients seen in the ED who will require procedural sedation for a painful procedure will be randomized to receive either propofol or propofol and ketamine. During the procedure, patients will be monitored per the standard of care, including use of a cardiac monitor, non-invasive blood pressure monitoring, pulse oximetry, nasal sample end-tidal carbon dioxide, and physician assessment. Once the procedure is successfully completed and the patient has returned to his/her baseline mental status, the patient will be asked to mark a 100 mm visual analog scale regarding perceived pain during the procedure, memory of the procedure, and overall satisfaction with the procedure.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing procedural sedation for an urgent procedure in the Emergency Department

Exclusion Criteria:

* Allergy to propofol or ketamine, intoxication, altered mental status, ASA physical status score \>2

Primary outcomes:
measure: Clinical Interventions During Sedation
timeFrame: From start of sedation procedure to end of sedation procedure, up to 24 hours
measure: Hypoxia
timeFrame: From start of sedation procedure to end of sedation procedure, up to 24 hours
Secondary outcomes:
measure: Respiratory Depression
timeFrame: From start of sedation procedure to end of sedation procedure, up to 24 hours
measure: Procedural Recall
timeFrame: Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Healthcare Research Institute
name: James R Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miner JR, Moore JC, Austad EJ, Plummer D, Hubbard L, Gray RO. Randomized, double-blinded, clinical trial of propofol, 1:1 propofol/ketamine, and 4:1 propofol/ketamine for deep procedural sedation in the emergency department. Ann Emerg Med. 2015 May;65(5):479-488.e2. doi: 10.1016/j.annemergmed.2014.08.046. Epub 2014 Oct 16.