Trial Outcomes & Findings for IN Sub-Dissociative Ketamine vs IN Fentanyl (NCT NCT02521415)

Last Updated: 2022-07-26

Results Overview

We will conclude that such a study is NOT feasible if we observe a rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related significant adverse events. Side effects are common events experienced by patients receiving ketamine or fentanyl that do not change outcomes for the patient but may affect the patient experience. A significant adverse event (SAE) includes any adverse event that begins after the short form consent has been completed that causes a threat to life, limb or an organ system, causes prolongation of hospitalization, or requires new medical or surgical treatment to correct.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

60 minutes

Results posted on

2022-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine ketamine (1mg/kg) ketamine: intranasal (IN) sub-dissociative ketamine (1mg/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Fentanyl fentanyl (1.5 micrograms/kg) fentanyl: Intranasal (IN) fentanyl (1.5 micrograms/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Overall Study STARTED	43	44
Overall Study COMPLETED	43	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IN Sub-Dissociative Ketamine vs IN Fentanyl

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=43 Participants ketamine (1mg/kg) ketamine: intranasal (IN) sub-dissociative ketamine (1mg/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Fentanyl n=44 Participants fentanyl (1.5 micrograms/kg) fentanyl: Intranasal (IN) fentanyl (1.5 micrograms/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Total n=87 Participants Total of all reporting groups
Age, Customized 4-10 years	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Age, Customized 11-17 years	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized African American/black	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized White	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	43 Participants n=5 Participants	44 Participants n=7 Participants	87 Participants n=5 Participants

PRIMARY outcome

Timeframe: 60 minutes

Outcome measures

Outcome measures
Measure	Ketamine n=43 Participants ketamine (1mg/kg) ketamine: intranasal (IN) sub-dissociative ketamine (1mg/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Fentanyl n=44 Participants fentanyl (1.5 micrograms/kg) fentanyl: Intranasal (IN) fentanyl (1.5 micrograms/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events serious adverse events	0 Participants	0 Participants
Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events non-serious adverse events	41 Participants	25 Participants
Primary Outcome: Number of Participants With Minor Side Effects and Significant Adverse Events no AEs observed	2 Participants	19 Participants

SECONDARY outcome

Timeframe: participants will be followed during the emergency department length of stay, estimated to average 6 hours

Compare the total dose of opioid pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected forearm fractures after randomization and treatment with IN ketamine or IN fentanyl.

Outcome measures

Outcome measures
Measure	Ketamine n=43 Participants ketamine (1mg/kg) ketamine: intranasal (IN) sub-dissociative ketamine (1mg/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Fentanyl n=44 Participants fentanyl (1.5 micrograms/kg) fentanyl: Intranasal (IN) fentanyl (1.5 micrograms/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Secondary Outcome: Total Dose of Opioid Pain Medication in Morphine Equivalents/kg/Hour	0.04 morphine equivalents/kg/hr Interval 0.02 to 0.11	0.05 morphine equivalents/kg/hr Interval 0.04 to 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 20 minutes

Mean difference in the reduction of the pain scale scores at 20 minutes. Two commonly used, age appropriate and previously validated, pediatric pain assessment tools were used: FACES Pain Scale - Revised for children ages 4-10 and the Visual Analog Scale for children ages 11-17. The FACES Pain Scale - Revised is a self-reported measure of pain intensity developed for children with pain intensity represented by images of grimacing faces on a scale of 0 (no pain) to 10 (maximum pain). The Visual Analog Scale is a self-reported measure of pain intensity where patients mark their pain level on a 10 cm line that represents a continuum of no pain at 0 cm and worst pain at 10 cm. For analysis, pain scale data were merged and reported as values form 0 to 100. The minimum clinically significant reduction in pain was defined as a decrease of 20.

Outcome measures

Outcome measures
Measure	Ketamine n=43 Participants ketamine (1mg/kg) ketamine: intranasal (IN) sub-dissociative ketamine (1mg/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Fentanyl n=44 Participants fentanyl (1.5 micrograms/kg) fentanyl: Intranasal (IN) fentanyl (1.5 micrograms/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
Exploratory Outcome: Reduction in Age Appropriate Pain Scale Scores	44 units on a scale Standard Deviation 36	35 units on a scale Standard Deviation 29

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 hours

Population: Data were collected but all secondary outcomes for the study have not yet been analyzed

Compare the frequency of types of adverse events over 6-hours among children randomized to receive either intranasal sub-dissociative ketamine (IN ketamine) or intranasal fentanyl (IN fentanyl) for pain control in the emergency department.

Outcome measures

Outcome data not reported

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Fentanyl

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=43 participants at risk ketamine (1mg/kg) ketamine: intranasal (IN) sub-dissociative ketamine (1mg/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention	Fentanyl n=44 participants at risk fentanyl (1.5 micrograms/kg) fentanyl: Intranasal (IN) fentanyl (1.5 micrograms/kg) ibuprofen or acetaminophen: 10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
General disorders any adverse event	95.3% 41/43 • Number of events 41 • Hour 6	56.8% 25/44 • Number of events 25 • Hour 6
General disorders bad taste in mouth/throat	86.0% 37/43 • Number of events 37 • Hour 6	20.5% 9/44 • Number of events 9 • Hour 6
Nervous system disorders dizziness	69.8% 30/43 • Number of events 30 • Hour 6	13.6% 6/44 • Number of events 6 • Hour 6
General disorders sleepiness	44.2% 19/43 • Number of events 19 • Hour 6	34.1% 15/44 • Number of events 15 • Hour 6
General disorders drowsiness	14.0% 6/43 • Number of events 6 • Hour 6	6.8% 3/44 • Number of events 3 • Hour 6
General disorders itchy nose	23.3% 10/43 • Number of events 10 • Hour 6	20.5% 9/44 • Number of events 9 • Hour 6
Eye disorders visual disturbance	9.3% 4/43 • Number of events 4 • Hour 6	2.3% 1/44 • Number of events 1 • Hour 6
General disorders dysphoria	2.3% 1/43 • Number of events 1 • Hour 6	4.5% 2/44 • Number of events 2 • Hour 6
Gastrointestinal disorders nausea	7.0% 3/43 • Number of events 3 • Hour 6	6.8% 3/44 • Number of events 3 • Hour 6

Additional Information

Dr. Stacy Reynolds

Carolinas Medical Center

Phone: 704-355-3181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place