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Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

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ClinicalTrials.gov Identifier: NCT01951963
Recruitment Status : Completed
First Posted : September 27, 2013
Results First Posted : October 16, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Ketamine
Drug: Morphine
Enrollment 77
Recruitment Details  
Pre-assignment Details 77 met eligibility criteria and 63 were randomized to one of the two study groups.
Arm/Group Title Ketamine Morphine
Hide Arm/Group Description

Ketamine, single dose, 0.3 mg/kg, IV

The final sample included 40 subjects, 20 in the Ketamine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team.

Morphine, single dose, 0.05 mg/kg, IV

The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team.

Period Title: Overall Study
Started 31 32
Completed 31 32
Not Completed 0 0
Arm/Group Title Ketamine Morphine Total
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Ketamine, single dose, 0.3 mg/kg, IV

The final sample included 40 subjects, 20 in the Ketamine group. Inclusion criteria was defined as, patients age 3-17 years old, medical or traumatic condition requiring intravenous opioid analgesics, ability to obtain consent from parents and assent from the patient. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team.

Morphine, single dose, 0.05 mg/kg, IV

The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team.

Total of all reporting groups
Overall Number of Baseline Participants 31 32 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
<=18 years
31
 100.0%
32
 100.0%
63
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 63 participants
13.3  (3.6) 12.7  (3.7) 13.0  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Female
12
  38.7%
9
  28.1%
21
  33.3%
Male
19
  61.3%
23
  71.9%
42
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 32 participants 63 participants
31 32 63
1.Primary Outcome
Title Cumulative Narcotic Consumption
Hide Description All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.
Time Frame 3 hours post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects in each group who received at least one dose of opioids post study drug.
Arm/Group Title Ketamine Morphine
Hide Arm/Group Description:

Ketamine, single dose, 0.3 mg/kg, IV

Ketamine

prospective, double blind, randomized control trial. After informed consent, patients 3-17 years old requiring intravenous analgesics were randomized to receive either a single dose of 0.3mg/kg ketamine or 0.05mg/kg morphine in addition to standard opioid based analgesia. These weight-based doses of Ketamine and Morphine are the standard recommended doses from the Lexicomp Drug Reference Handbook, Pediatric and Neonatal Dosing (2011-2012).

Morphine, single dose, 0.05 mg/kg, IV

Morphine

prospective, double blind, randomized control trial. After informed consent, patients 3-17 years old requiring intravenous analgesics were randomized to receive either a single dose of 0.3mg/kg ketamine or 0.05mg/kg morphine in addition to standard opioid based analgesia. These weight-based doses of Ketamine and Morphine are the standard recommended doses from the Lexicomp Drug Reference Handbook, Pediatric and Neonatal Dosing (2011-2012).

Overall Number of Participants Analyzed 31 32
Measure Type: Count of Participants
Unit of Measure: Participants
19
  61.3%
14
  43.8%
2.Primary Outcome
Title Adverse Drug Reaction
Hide Description Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.
Time Frame 3 hours post study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED will be compared using unadjusted Fisher's exact of a composite measure (≤ 1 events vs. > 1).
Arm/Group Title Ketamine Morphine
Hide Arm/Group Description:

Ketamine, single dose, 0.3 mg/kg, IV

Ketamine

Morphine, single dose, 0.05 mg/kg, IV

Morphine

Overall Number of Participants Analyzed 31 32
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.5%
3
   9.4%
3.Other Pre-specified Outcome
Title Pain Scale Rating Agreement Among Patient, Parent, and Research Staff
Hide Description

FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.

  • FLACC - Parents 30 Minutes Post dose
  • FLACC - Staff 30 Minutes Post dose

Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain.

Time Frame Up to 3 hours post pain medication administration
Hide Outcome Measure Data
Hide Analysis Population Description
Wong-Baker Faces scale is a self-assessment of pain Scale. FLACC Score (FLACC = Face, Legs, Activity, Crying and Consolability) is a behavioral observational pain rating scale that looks for specific behaviors and scores them. Both scales are scored 0-10 with 0 representing no pain. Lower scores are better outcomes.
Arm/Group Title Ketamine Morphine
Hide Arm/Group Description:

Ketamine, single dose, 0.3 mg/kg, IV

The final sample included 40 subjects, 20 in the Ketamine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of ketamine (0.3 mg/kg). These are standard recommended pediatric weight-based analgesic doses of Ketamine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team.

Morphine, single dose, 0.05 mg/kg, IV

The final sample included 40 subjects, 20 in the Morphine group. The baseline characteristics were similar between the two groups. These patients were randomized to receive a single bolus of morphine (0.05mg/kg). These are standard recommended pediatric weight-based analgesic doses of Morphine. Patient weight was obtained by the treating RN using a scale or Broselow tape. A blinded 10mL syringe containing study drug was prepared and delivered to the bedside by a pharmacist. After administration of study drug all future analgesic doses were restricted to morphine and were given at the discretion of the treatment team.

Overall Number of Participants Analyzed 31 32
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
FLACC - Staff 30 Minutes Post dose 1.1  (1.7) 1.1  (1.6)
FLACC - Parents 30 Minutes Post dose 2.0  (2.1) 1.9  (1.9)
Wong-Baker Faces pain scale changes -3.5  (2.4) -3.7  (2.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Morphine
Hide Arm/Group Description

Ketamine, single dose, 0.3 mg/kg, IV

Ketamine

Morphine, single dose, 0.05 mg/kg, IV

Morphine

All-Cause Mortality
Ketamine Morphine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ketamine Morphine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/32 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Morphine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/31 (6.45%)      2/32 (6.25%)    
Gastrointestinal disorders     
vomiting/nausea   0/31 (0.00%)  0 1/32 (3.13%)  1
Skin and subcutaneous tissue disorders     
Allergic Reaction to study drug  [1]  2/31 (6.45%)  2 2/32 (6.25%)  2
Indicates events were collected by systematic assessment
[1]
Rash
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: Dr. Aaron Burnett
Organization: Health Partners
Phone: 651-254-5304
EMail: Aaron.M.Burnett@HealthPartners.Com
Layout table for additonal information
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01951963    
Other Study ID Numbers: A12-158
First Submitted: September 24, 2013
First Posted: September 27, 2013
Results First Submitted: February 16, 2017
Results First Posted: October 16, 2017
Last Update Posted: July 3, 2018