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Study to Find the Dose of Rapidly Administered Ketamine for Brief Painful Procedures in Children

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ClinicalTrials.gov Identifier: NCT01669642
Recruitment Status : Completed
First Posted : August 21, 2012
Results First Posted : March 12, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Abscess
Fracture
Intervention Drug: Ketamine
Enrollment 111
Recruitment Details children between 2-18 years of age who presented to st louis children's hospital emergency department between april 2012 and august 2014 with a fracture that needed reduction or a skin abscess that needed drainage under sedation were approached for enrollment.
Pre-assignment Details  
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years Abscess Drainage Group 12-17 Years
Hide Arm/Group Description children between 2-5 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group. children between 6-11 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group. children between 12-17 years who needs ketamine sedation for fracture reduction in the emergency department are enrolled in this group. children between 2-5 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group. children between 6-11 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group. children between 12-17 years who needs ketamine sedation for abscess drainage in the emergency department are enrolled in this group.
Period Title: Overall Study
Started 20 20 20 21 20 10
Completed 20 20 20 20 20 0
Not Completed 0 0 0 1 0 10
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years Total
Hide Arm/Group Description participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 20 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
4.8
(2.9 to 5.9)
9.2
(6 to 11.9)
13.7
(12.6 to 16.9)
2.9
(2 to 5.1)
7.2
(6.4 to 11.9)
7.2
(2.9 to 11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
Female
9
  45.0%
6
  30.0%
1
   5.0%
8
  40.0%
11
  55.0%
35
  35.0%
Male
11
  55.0%
14
  70.0%
19
  95.0%
12
  60.0%
9
  45.0%
65
  65.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
african american
5
  25.0%
2
  10.0%
8
  40.0%
9
  45.0%
8
  40.0%
32
  32.0%
Caucasian
13
  65.0%
1
   5.0%
2
  10.0%
10
  50.0%
12
  60.0%
38
  38.0%
other
2
  10.0%
17
  85.0%
10
  50.0%
1
   5.0%
0
   0.0%
30
  30.0%
Patients who received Opioids prior to sedation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
19
  95.0%
18
  90.0%
19
  95.0%
0
   0.0%
0
   0.0%
56
  56.0%
time between opioid administration and sedation start time  
Median (Full Range)
Unit of measure:  Minutes
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
116
(20 to 383)
96
(1 to 251)
129
(27 to 401)
0
(0 to 0)
0
(0 to 0)
116
(1 to 401)
fracture characteristics  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 20 participants 100 participants
Non displaced fracture
10
  50.0%
2
  10.0%
9
  45.0%
0
   0.0%
0
   0.0%
21
  21.0%
displaced fracture but not overriding
6
  30.0%
11
  55.0%
7
  35.0%
0
   0.0%
0
   0.0%
24
  24.0%
displaced fracture and overriding
4
  20.0%
7
  35.0%
4
  20.0%
0
   0.0%
0
   0.0%
15
  15.0%
no fracture
0
   0.0%
0
   0.0%
0
   0.0%
20
 100.0%
20
 100.0%
40
  40.0%
1.Primary Outcome
Title Median Effective Dose (ED50) and ED95 of Rapidly Administered Ketamine
Hide Description ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.
Time Frame Dose administration through 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
100 children were enrolled in 5 different groups depending on the age and type of procedure.
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Hide Arm/Group Description:
children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Overall Number of Participants Analyzed 20 20 20 20 20
Median (Full Range)
Unit of Measure: mg/kg of ketamine dose
0.7
(0.6 to 0.9)
0.5
(0.5 to 0.7)
0.6
(0.5 to 0.8)
0.9
(0.7 to 1.1)
0.6
(0.4 to 0.9)
2.Primary Outcome
Title ED95
Hide Description ED95 is the dose of ketamine effective for 95% of children. this outcome is estimated from ED50.
Time Frame Dose administration through 5 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Hide Arm/Group Description:
participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Number
Unit of Measure: mg/kg of ketamine dose
0.7 0.7 0.8 1.1 1.1
3.Secondary Outcome
Title Vomiting
Hide Description patients who experienced vomiting while in the ED or after discharge
Time Frame Administration of ketamine through 2 week follow up call
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Hide Arm/Group Description:
children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
vomiting in the ED
1
   5.0%
1
   5.0%
1
   5.0%
1
   5.0%
0
   0.0%
Vomiting after discharge
6
  30.0%
3
  15.0%
3
  15.0%
2
  10.0%
1
   5.0%
No vomiting
13
  65.0%
16
  80.0%
16
  80.0%
17
  85.0%
19
  95.0%
4.Secondary Outcome
Title Number of Participants With Wisconsin Sedation Scale Score of 2 or Less at 1 Minute After First Dose of Ketamine
Hide Description

This is a measure of sedation effectiveness; to assess the effectiveness of first dose of ketamine administered.

Possible values for the scale range from 0 to 6. A sedation score of 2 or less is considered adequate sedation. Values more than 2 indicate state of inadequate sedation. higher values indicate the need for additional doses of sedation.

Patients who achieved a score of 2 or less are considered effective sedation and a score of >2 are considered ineffective sedations.

Time Frame Dose administration through 1 minute
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Hide Arm/Group Description:
children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Overall Number of Participants Analyzed 20 20 20 20 20
Measure Type: Number
Unit of Measure: participants
12 9 10 13 10
5.Other Pre-specified Outcome
Title Total Sedation Time
Hide Description during recovery, all participants are monitored for recovery to baseline at which point participants are ready for discharge. we will document the time from induction to recovery to aldrete score of 10.
Time Frame Time of administration of ketamine through sedation recovery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Hide Arm/Group Description:
children between 2-5 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 12-17 years of age who need fracture reduction under ketamine sedation are enrolled in this group.
children between 2-5 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
children between 6-11 years of age who need abscess drainage under ketamine sedation are enrolled in this group.
Overall Number of Participants Analyzed 20 20 20 20 20
Median (Full Range)
Unit of Measure: minutes
Patients requiring single dose of ketamine
25
(15 to 30)
22.5
(15 to 31)
25
(25 to 30)
20.5
(13 to 40)
17.5
(10 to 40)
patients requiring more than single dose
35
(25 to 85)
25
(15 to 50)
45
(20 to 80)
27.5
(16 to 40)
35
(10 to 60)
Time Frame from the day of enrollment up to 2 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Hide Arm/Group Description participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for fracture reduction will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute. participants who need ketamine sedation for abscess drainage will be approached for enrollment. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
All-Cause Mortality
Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fracture Reduction Group 2-5 Years Fracture Reduction Group 6-11 Years Fracture Reduction Group 12-17 Years Abscess Drainage Group 2-5 Years Abscess Drainage Group 6-11 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/20 (35.00%)      5/20 (25.00%)      7/20 (35.00%)      3/20 (15.00%)      2/20 (10.00%)    
Gastrointestinal disorders           
vomiting   7/20 (35.00%)  7 4/20 (20.00%)  4 4/20 (20.00%)  4 3/20 (15.00%)  3 1/20 (5.00%)  1
Nervous system disorders           
dysphoria, ag  [1]  0/20 (0.00%)  0 1/20 (5.00%)  1 3/20 (15.00%)  3 0/20 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
patients who experienced dysphoria during sedation or recovery period
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SRI SANKAR CHINTA PI
Organization: washington university in st louis
Phone: 3144544661
EMail: schinta@wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01669642     History of Changes
Other Study ID Numbers: 201112017
First Submitted: August 8, 2012
First Posted: August 21, 2012
Results First Submitted: February 12, 2018
Results First Posted: March 12, 2018
Last Update Posted: April 25, 2019