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

NCT02356705 | Completed Phase 4 Results

• 1 other identifier: 1098
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pediatric Pre-Induction Anesthesia Scale at Arrival to Operating Room

  20 minutes

Other Outcomes (4)

• Time to Discharge

  approximately 3 hours

• Number of Participants With Nosebleeds From Time of Drug Administration to Discharge Home

  approximately 3 hours

• Observational Distress Score at 1 Minute (Blinded Study Nurse Assessment)

  1 minute

Study Arms (3)

Saline Placebo

PLACEBO COMPARATOR

Control patients will receive intranasal saline

Drug: saline placebo

Nasal Midazolam Only

ACTIVE COMPARATOR

Patients will receive 0.2 mg/kg of intranasal midazolam

Drug: Midazolam

Midazolam Plus Xylocaine

ACTIVE COMPARATOR

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; Drug: xylocaine

Interventions

Midazolam DRUG

midazolam 0.2 mg/kg given intranasally

Midazolam Plus Xylocaine; Nasal Midazolam Only

xylocaine DRUG

intransal xylocaine given in conjunction with intranasal midazolam

Midazolam Plus Xylocaine

saline placebo DRUG

intranasal saline given as placebo

Saline Placebo

Eligibility Criteria

• Age: 18 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jennifer Victory, RN, CCRC: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

MeSH Terms

Interventions

Midazolam; Lidocaine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. David Ullman
• Organization: Bassett Healthcare

doccfi@hotmail.com

585-750-7510

Study Officials

• david Ullman, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Nurse Supervisor

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 5, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 16, 2022
• Results First Posted: February 25, 2021

Record last verified: 2022-03

Locations

US (1)