Trial Outcomes & Findings for Intranasal Midazolam in Children as a Pre-Operative Sedative

Results Overview

Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1\. Agitated: Previous criteria and/or refuses mask. (worst score) * 2\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3\. Calm: Previous criteria and accepts mask. * 4\. Drowsy: Previous criteria and accepts mask. * 5\. Asleep: Previous criteria and accepts mask. (best score)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

25 minutes

Results posted on

2022-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Saline Placebo Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Overall Study STARTED	14	14	14
Overall Study COMPLETED	14	14	14
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam	Total n=42 Participants Total of all reporting groups
Age, Continuous	2.4 years STANDARD_DEVIATION 1.7 • n=14 Participants	3.1 years STANDARD_DEVIATION 1.5 • n=14 Participants	2.5 years STANDARD_DEVIATION 1.7 • n=14 Participants	2.7 years STANDARD_DEVIATION 1.6 • n=42 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	5 Participants n=14 Participants	10 Participants n=14 Participants	22 Participants n=42 Participants
Sex: Female, Male Male	7 Participants n=14 Participants	9 Participants n=14 Participants	4 Participants n=14 Participants	20 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	14 participants n=14 Participants	14 participants n=14 Participants	42 participants n=42 Participants

PRIMARY outcome

Timeframe: 25 minutes

Pediatric Response to Mask Placement Scale - scaled scored by the anesthesiologist or certified nurse anesthetist (CRNA) at the time of mask placement * 1\. Agitated: Previous criteria and/or refuses mask. (worst score) * 2\. Alert: Previous criteria and/or initially refuses mask, but accept after persuasion. * 3\. Calm: Previous criteria and accepts mask. * 4\. Drowsy: Previous criteria and accepts mask. * 5\. Asleep: Previous criteria and accepts mask. (best score)

Outcome measures

Outcome measures
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement Agitated	11 Participants	3 Participants	6 Participants
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement Alert	1 Participants	1 Participants	3 Participants
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement Calm	2 Participants	10 Participants	4 Participants
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement Drowsy	0 Participants	0 Participants	1 Participants
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement Asleep	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 20 minutes

Pediatric Pre-Induction Anesthesia Scale - scored by the anesthesiologist or the CRNA upon arrival to the operating room, prior to induction of anesthesia * 1\. Agitated: Patient clinging to parents and/or crying (worst score) * 2\. Alert: Patient is aware but not clinging to parent, may whimper but not cry. * 3\. Calm: Sitting or lying comfortably with spontaneous eye opening. * 4\. Drowsy: Sitting or lying comfortably with eyes closed, but responding to minor stimulation. * 5\. Asleep: Eyes closed, arousable but does not respond to minor stimulation. (best score)

Outcome measures

Outcome measures
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room Agitated	5 Participants	1 Participants	1 Participants
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room Alert	1 Participants	3 Participants	3 Participants
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room Calm	8 Participants	9 Participants	9 Participants
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room Drowsy	0 Participants	1 Participants	1 Participants
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room Asleep	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: approximately 3 hours

The time (in minutes) from release from the operating room to discharge home

Outcome measures

Outcome measures
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Time to Discharge	35 minutes Interval 29.0 to 44.0	39.5 minutes Interval 22.0 to 50.0	35.5 minutes Interval 31.0 to 45.0

OTHER_PRE_SPECIFIED outcome

Timeframe: approximately 3 hours

Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration.

Outcome measures

Outcome measures
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 minute

Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse.

Outcome measures

Outcome measures
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)	0.02 cm VAS Interval 0.0 to 0.1	0.3 cm VAS Interval 0.1 to 0.6	0.4 cm VAS Interval 0.01 to 0.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 5minutes

Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse.

Outcome measures

Outcome measures
Measure	Saline Placebo n=14 Participants Control patients will receive intranasal saline saline placebo: intranasal saline given as placebo	Nasal Midazolam Only n=14 Participants Patients will receive 0.2 mg/kg of intranasal midazolam Midazolam: midazolam 0.2 mg/kg given intranasally	Midazolam Plus Xylocaine n=14 Participants Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 50% of the volume of the midazolam. Midazolam: midazolam 0.2 mg/kg given intranasally xylocaine: intransal xylocaine given in conjunction with intranasal midazolam
Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet)	0 cm VAS Interval 0.0 to 0.02	0.02 cm VAS Interval 0.0 to 0.2	0 cm VAS Interval 0.0 to 0.01

Adverse Events

Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nasal Midazolam Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam Plus Xylocaine

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. David Ullman

Bassett Healthcare

Phone: 585-750-7510

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Trial Outcomes & Findings for Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2 (NCT NCT02356705)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

OTHER_PRE_SPECIFIED outcome

Outcome measures

Adverse Events

Saline Placebo

Nasal Midazolam Only

Midazolam Plus Xylocaine

Serious adverse events

Other adverse events

Additional Information

Dr. David Ullman

Results disclosure agreements