Intranasal Midazolam in Children as a Pre-Operative Sedative - Part 2

Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative. This is follow up to the pilot study, Project # 994. This will expand the previous study, with additional participants and revised xylocaine concentration

Study Overview

• Status: Completed
• Conditions: Sedation
• Intervention / Treatment: Drug: saline placebo; Drug: Midazolam; Drug: xylocaine

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children aged 18 months-7 years, scheduled for a minor Ear/Nose/Throat surgical procedure requiring mask anesthesia
2. American Society of Anesthesiologists (ASA) Class 1 or 2
3. Parent willing and able to provide written informed consent
4. Parent willing and able to complete the Observed Behavioral Distress (OBD) Visual Assessment Scale (VAS)

Exclusion Criteria:

1. ASA Class 3 or greater
2. History of allergy to midazolam or xylocaine
3. Presence of acute respiratory infection at time of surgery
4. Parent unwilling or unable to provide informed consent
5. Parent unwilling or unable to complete the OBD VAS

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline Placebo; Control patients will receive intranasal saline	Drug: saline placebo; intranasal saline given as placebo
Active Comparator: Nasal Midazolam Only; Patients will receive 0.2 mg/kg of intranasal midazolam	Drug: Midazolam; midazolam 0.2 mg/kg given intranasally
Active Comparator: 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.	Drug: Midazolam; midazolam 0.2 mg/kg given intranasally; Drug: xylocaine; intransal xylocaine given in conjunction with intranasal midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Pre-Induction Anesthesia Scale at Time of Mask Placement	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)	25 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room	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)	20 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Discharge	The time (in minutes) from release from the operating room to discharge home	approximately 3 hours
Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home	Number of participants with nosebleeds recorded in the pre-operative, intra-operative and post-operative record after study drug administration.	approximately 3 hours
Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)	Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress). Recorded by the blinded study nurse.	1 minute
Observational Distress Score 5 Min (Blinded Study Nurse Assessmnet)	Visual analog scale measured from 0cm (no distress) to 10cm (high level of distress) as measured by the blinded study nurse.	5minutes

Collaborators and Investigators

• Sponsor: Jennifer Victory, RN, CCRC
• Investigators: Principal Investigator: david Ullman, MD, Bassett Healthcare

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: February 4, 2015
• First Posted (Estimate): February 5, 2015

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Midazolam; Lidocaine
• Other Study ID Numbers: 1098