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

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356705
• Other study ID #: 1098
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2022
• Source: Bassett Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Midazolam
midazolam 0.2 mg/kg given intranasally
• xylocaine
intransal xylocaine given in conjunction with intranasal midazolam
• saline placebo
intranasal saline given as placebo

Locations

Country	Name	City	State
United States	Bassett Healthcare Network	Cooperstown	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer Victory, RN, CCRC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Discharge	The time (in minutes) from release from the operating room to discharge home	approximately 3 hours
Other	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
Other	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
Other	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
Primary	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	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