Trial Outcomes & Findings for Sub-dissociative Ketamine for the Management of Acute Pediatric Pain (NCT NCT01951963)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

77 participants

Primary outcome timeframe

3 hours post study drug administration

Results posted on

2018-07-03

Participant Flow

77 met eligibility criteria and 63 were randomized to one of the two study groups.

Participant milestones

Participant milestones
Measure	Ketamine 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 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 Study STARTED	31	32
Overall Study COMPLETED	31	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sub-dissociative Ketamine for the Management of Acute Pediatric Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=31 Participants 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 n=32 Participants 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 n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	13.3 years STANDARD_DEVIATION 3.6 • n=5 Participants	12.7 years STANDARD_DEVIATION 3.7 • n=7 Participants	13.0 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	32 participants n=7 Participants	63 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 hours post study drug administration

Population: The number of subjects in each group who received at least one dose of opioids post study drug.

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.

Outcome measures

Outcome measures
Measure	Ketamine n=31 Participants Ketamine, single dose, 0.3 mg/kg, IV Ketamine	Morphine n=32 Participants Morphine, single dose, 0.05 mg/kg, IV Morphine
Cumulative Narcotic Consumption	19 Participants	14 Participants

PRIMARY outcome

Timeframe: 3 hours post study drug administration

Population: 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).

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.

Outcome measures

Outcome measures
Measure	Ketamine n=31 Participants Ketamine, single dose, 0.3 mg/kg, IV Ketamine	Morphine n=32 Participants Morphine, single dose, 0.05 mg/kg, IV Morphine
Adverse Drug Reaction	2 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 hours post pain medication administration

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Ketamine n=31 Participants Ketamine, single dose, 0.3 mg/kg, IV Ketamine	Morphine n=32 Participants Morphine, single dose, 0.05 mg/kg, IV Morphine
Pain Scale Rating Agreement Among Patient, Parent, and Research Staff FLACC - Staff 30 Minutes Post dose	1.1 Scores on a scale Standard Deviation 1.7	1.1 Scores on a scale Standard Deviation 1.6
Pain Scale Rating Agreement Among Patient, Parent, and Research Staff FLACC - Parents 30 Minutes Post dose	2.0 Scores on a scale Standard Deviation 2.1	1.9 Scores on a scale Standard Deviation 1.9
Pain Scale Rating Agreement Among Patient, Parent, and Research Staff Wong-Baker Faces pain scale changes	-3.5 Scores on a scale Standard Deviation 2.4	-3.7 Scores on a scale Standard Deviation 2.4

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Morphine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=31 participants at risk Ketamine, single dose, 0.3 mg/kg, IV Ketamine	Morphine n=32 participants at risk Morphine, single dose, 0.05 mg/kg, IV Morphine
Skin and subcutaneous tissue disorders Allergic Reaction to study drug	6.5% 2/31 • Number of events 2	6.2% 2/32 • Number of events 2
Gastrointestinal disorders vomiting/nausea	0.00% 0/31	3.1% 1/32 • Number of events 1

Additional Information

Dr. Aaron Burnett

Health Partners

Phone: 651-254-5304

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place