Intranasal Midazolam in Children as a Pre-Operative Sedative

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.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• 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 otolaryngology (ENT) 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 OBD 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; saline placebo	Drug: saline placebo; Placebo - Control patients will receive intranasal saline.
Active Comparator: Nasal Midazolam only; Nasal Midazolam only - Patients received 0.2 mg/kg of intranasal midazolam	Drug: Midazolam; Study participants will be randomly assigned to one of three treatment groups: Group 1 - Placebo - Control patients will receive intranasal saline.; Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.; Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.; Other Names: versed
Active Comparator: Midazolam and Xylocaine; Midazolam Plus Xylocaine - Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam	Drug: Midazolam; Study participants will be randomly assigned to one of three treatment groups: Group 1 - Placebo - Control patients will receive intranasal saline.; Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.; Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.; Other Names: versed; Drug: xylocaine; Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Scale Score	Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.	10 minutes post-sedation
Sedation Scale Score	Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.	15 minutes post-sedation
Time From Administration to Discharge		Minutes from administration to discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Observed Behavioral Distress Score	Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).	1 minute post-administration
RN Observed Behavioral Distress Score	Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).	1 minute post-administration
Verbal Complaint	Recorded by the administering RN at the time of administration.	At time of administration
Verbal Complaints	Recorded by the administering RN at one minute post-administration	1 minute post-administration

Collaborators and Investigators

• Sponsor: Bassett Healthcare
• Investigators: Principal Investigator: david Ullman, MD, Bassett Healthcare

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: June 25, 2015
• Last Verified: June 1, 2015

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: 994