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Ketamine Versus Co-administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT01387139
Collaborator
Colorado Clinical & Translational Sciences Institute (Other)
183
Enrollment
1
Location
2
Arms
82.1
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the effectiveness of the co-administration of intravenous ketamine and propofol to intravenous ketamine as a single agent for procedural sedation in the pediatric emergency department. The investigators hypothesize that patients receiving co-administration of ketamine and propofol will have a lower rate of adverse events, compared to patients receiving ketamine for procedural sedation.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Procedural sedation and analgesia (PSA) is a frequent occurrence in pediatric emergency departments. The goals of PSA include maximizing analgesia and amnesia, and minimizing adverse events while ensuring stable cardiopulmonary function. For decades, ketamine has been the main pharmacologic agent used for pediatric PSA. Numerous studies support the use of ketamine for sedation, amnesia, and analgesia on children undergoing painful procedures in the emergency department setting. Research has continually shown ketamine to cause emergence phenomenon, laryngospasm and vomiting.

Propofol is a sedative-hypnotic widely used for procedural sedation in adult emergency departments. The advantages of propofol include rapid onset, with quick and predictable recovery time, and antiemetic effects. Disadvantages include dose-dependent hypotension, bradycardia, respiratory depression, as well as pain with injection. In addition, propofol does not provide any analgesia.

Ketamine and propofol administered together have been successfully utilized in a variety of settings, including dermatologic, cardiovascular, and interventional radiological procedures in children. The co-administration of ketamine and propofol has been shown to preserve sedation while minimizing the respective adverse events. When used in combination, doses administered of each can be reduced, while producing a more stable hemodynamic and respiratory profile. Furthermore, this combination may reduce the frequency of emergence reactions, vomiting, and the pain of propofol injection.

To date, there are no randomized controlled trials evaluating the co-administration of ketamine and propofol versus ketamine monotherapy for PSA in the Pediatric Emergency Department.

Study Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of Ketamine Versus Co-Administration of Ketamine and Propofol for Procedural Sedation in a Pediatric Emergency Department
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Nov 3, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ketamine Alone

1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)

Drug: Ketamine
1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
Experimental: Ketamine Co-Administered with Propofol

0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)

Drug: Ketamine Co-administered with Propofol
0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)

Outcome Measures

Primary Outcome Measures

  1. Frequency of Adverse Events [From enrollment through completion of follow-up, up to 7 days]

    We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.

Secondary Outcome Measures

  1. Recovery Time [Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour]

    Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.

  2. Efficacy of Sedation [After procedure is completed, on average less than 1 hour]

    Efficacy is defined as: The patient does not have unpleasant recall of the procedure. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint. The procedure was successful

  3. Parent Satisfaction [After procedure is completed, on average less than 1 hour]

    Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

  4. Physician Performing Procedure Satisfaction [After procedure is completed, on average less than 1 hour]

    Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

  5. Nurse Satisfaction [After procedure is completed, on average less than 1 hour]

    Measured on a 10-point scale (1= least satisfied, 10= most satisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Ages > 3 years and < 21 years

  • American Society of Anesthesiologists (ASA) class I or II

  • Fracture or dislocation requiring reduction under procedural sedation with ketamine as deemed by the attending emergency medicine physician

  • Parent/Legal Guardian or Patient (if 18 years of age or older) has already given verbal consent for procedural sedation as part of standard care for their condition

Exclusion Criteria:

  • Hypertension (Blood Pressure > 95th percentile for age)

  • Glaucoma or acute globe injury

  • Increased intracranial pressure or central nervous system mass lesion

  • Porphyria

  • Previous allergic reaction to ketamine

  • Previous allergic reaction to Propofol or its components including soybean oil, glycerol, egg lecithin, and disodium edentate

  • Disorders of lipid metabolism including primary hyperlipoproteinemia, diabetic hyperlipemia, or pancreatitis

  • Mitochondrial myopathies or disorders of electron transport

  • Pregnancy

  • Parent, guardian or patient unwilling/unable to provide informed consent/assent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital Colorado Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • Colorado Clinical & Translational Sciences Institute

Investigators

  • Principal Investigator: Lalit Bajaj, MD, MPH, University of Colorado, Denver
  • Principal Investigator: Keith Weisz, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01387139
Other Study ID Numbers:
  • 10-0835
First Posted:
Jul 4, 2011
Last Update Posted:
Dec 8, 2017
Last Verified:
Nov 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Colorado, Denver
Ketamine
Propofol
Procedural Sedation and Analgesia
Additional relevant MeSH terms:
Emergencies
Ketamine
Propofol

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person) Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
Period Title: Overall Study
STARTED 99 84
COMPLETED 99 84
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol Total
Arm/Group Description Total of all reporting groups
Overall Participants 99 84 183
Age (Count of Participants)
<=18 years
99
100%
84
100%
183
100%
Between 18 and 65 years
0
0%
0
0%
0
0%
>=65 years
0
0%
0
0%
0
0%
Sex: Female, Male (Count of Participants)
Female
25
25.3%
30
35.7%
55
30.1%
Male
74
74.7%
54
64.3%
128
69.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
1
1%
0
0%
1
0.5%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
6
6.1%
10
11.9%
16
8.7%
White
72
72.7%
62
73.8%
134
73.2%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
20
20.2%
12
14.3%
32
17.5%
Region of Enrollment (participants) [Number]
United States
99
100%
84
100%
183
100%

Outcome Measures

1. Primary Outcome
Title Frequency of Adverse Events
Description We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.
Time Frame From enrollment through completion of follow-up, up to 7 days

Outcome Measure Data

Analysis Population Description
Adverse events
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
Measure Participants 99 84
Respiratory depression
12
12.1%
15
17.9%
Cardiovascular event
1
1%
0
0%
vomiting/retching
21
21.2%
18
21.4%
Unpleasant recovery reaction
4
4%
2
2.4%
2. Secondary Outcome
Title Recovery Time
Description Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.
Time Frame Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
Measure Participants 99 84
Median (Inter-Quartile Range) [minutes]
44
43.5
3. Secondary Outcome
Title Efficacy of Sedation
Description Efficacy is defined as: The patient does not have unpleasant recall of the procedure. The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint. The procedure was successful
Time Frame After procedure is completed, on average less than 1 hour

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
Measure Participants 99 84
Number [participants]
97
98%
81
96.4%
4. Secondary Outcome
Title Parent Satisfaction
Description Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time Frame After procedure is completed, on average less than 1 hour

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
Measure Participants 99 84
Median (Inter-Quartile Range) [units on a scale (1-10)]
10
10
5. Secondary Outcome
Title Physician Performing Procedure Satisfaction
Description Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time Frame After procedure is completed, on average less than 1 hour

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
Measure Participants 99 84
Median (Inter-Quartile Range) [units on a scale]
9
8
6. Secondary Outcome
Title Nurse Satisfaction
Description Measured on a 10-point scale (1= least satisfied, 10= most satisfied)
Time Frame After procedure is completed, on average less than 1 hour

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
Measure Participants 99 84
Median (Inter-Quartile Range) [units on a scale]
10
8

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Ketamine Alone Ketamine Co-Administered With Propofol
Arm/Group Description
All Cause Mortality
Ketamine Alone Ketamine Co-Administered With Propofol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Ketamine Alone Ketamine Co-Administered With Propofol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/99 (0%) 0/84 (0%)
Other (Not Including Serious) Adverse Events
Ketamine Alone Ketamine Co-Administered With Propofol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 38/99 (38.4%) 33/84 (39.3%)
Cardiac disorders
Cardiovascular event 1/99 (1%) 1 0/84 (0%) 0
Gastrointestinal disorders
Vomiting 21/99 (21.2%) 21 18/84 (21.4%) 18
Psychiatric disorders
Unpleasant recovery Reaction 4/99 (4%) 4 2/84 (2.4%) 2
Respiratory, thoracic and mediastinal disorders
Respiratory depression 12/99 (12.1%) 12 15/84 (17.9%) 15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Keith Weisz
Organization Ucolorado
Phone 303-724-2592
Email keith.weisz@childrenscolorado.org
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01387139
Other Study ID Numbers:
  • 10-0835
First Posted:
Jul 4, 2011
Last Update Posted:
Dec 8, 2017
Last Verified:
Nov 1, 2017