Trial Outcomes & Findings for IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair (NCT NCT03528512)

Results Overview

The primary outcome variable is the maximum sedation score as measured by the University of Michigan Sedation Scale. This scale consists of an ordinal scale from 0 being awake and alert and 4 being unarousable. Medians will be calculated for each group.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

5 participants

Primary outcome timeframe

up to 30 minutes

Results posted on

2021-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	IN Ketamine Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

IN Ketamine vs IN Midazolam and Fentanyl for Laceration Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IN Ketamine n=3 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=2 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)	Total n=5 Participants Total of all reporting groups
Age, Continuous	2 years STANDARD_DEVIATION 0.87 • n=93 Participants	2 years STANDARD_DEVIATION 0 • n=4 Participants	2 years STANDARD_DEVIATION 0.61 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	3 participants n=93 Participants	2 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: up to 30 minutes

The primary outcome variable is the maximum sedation score as measured by the University of Michigan Sedation Scale. This scale consists of an ordinal scale from 0 being awake and alert and 4 being unarousable. Medians will be calculated for each group.

Outcome measures

Outcome measures
Measure	IN Ketamine n=3 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=2 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Sedation Score	1 units on a scale Interval 0.5 to 1.0	1 units on a scale Interval 1.0 to 1.0

PRIMARY outcome

Timeframe: Up to 30 minutes

The proportion of children who receive a maximum sedation score of either 1 or 2 (without distinguishing between those values)

Outcome measures

Outcome measures
Measure	IN Ketamine n=3 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=2 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Proportion of Children With Maximum Sedation Score	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 30 minutes

The effect of IN ketamine vs IN midazolam + IN fentanyl on pain scores during laceration repair using either Face, Legs, Activity, Cry, Consolability (FLACC) Scale or Faces Scale pain scale depending for patient age, each a Likert scale from 0 being no pain to 10 being worst pain, median scores for each group

Outcome measures

Outcome measures
Measure	IN Ketamine n=3 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=2 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Pain Scores During Laceration Repair	4 units on a scale Interval 4.0 to 4.5	0 units on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 30 minutes

Population: Two provider surveys were available for each patient experience

Nurse and physician satisfaction will be assessed by a survey which will be filled in the end of the sedation. Response to overall experience question score on Likert scale where 1 is poor and 5 is Excellent. Proportion of responders giving answers of 4 or 5 will be calculated.

Outcome measures

Outcome measures
Measure	IN Ketamine n=6 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=4 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Nurse and Physician Satisfaction	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 30 minutes

Rates of failure to repair laceration due to agitation or intolerable pain with the switch to intravenous medications will be compared between two groups. Percentage failure will be reported.

Outcome measures

Outcome measures
Measure	IN Ketamine n=3 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=2 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Rates of Failure	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 30 minutes

Proportion of children who have any significant change in vitals during analgosedation (any desaturation - Oxygen saturation \< 90, and hypotension per age-related norms) will be compared between the two groups.

Outcome measures

Outcome measures
Measure	IN Ketamine n=3 Participants Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml) Ketamine: Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)	IN Midazolam and Fentanyl n=2 Participants Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg) Midazolam and fentanyl: Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
Change in Vitals	0 Participants	0 Participants

Adverse Events

IN Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IN Midazolam and Fentanyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Margaret Menoch

William Beaumont Hospitals

Phone: 2489897289

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place