Pediatric Delirium

Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.

Preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal Dexmedetomidine and oral Midazolam.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Delirium
• Intervention / Treatment: Drug: Intra-nasal Dexmedetomidine; Drug: Oral Midazolam

Detailed Description

Pediatric ambulatory patients will randomly be allocated to one of two groups. Group A which will receive Dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or Group B which will receive Midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. Each subject will receive a Drug Acceptance scale, and Parental Separation Anxiety Scale (PSAS) mask Acceptance Scale to identify the differences in markers associated with pediatric delirium. End tidal Sevoflurane value during the surgery and at the time when patient leaves the OR, amount and dose of oral/rectal acetaminophen given in PACU, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Katherine Vlahcevic; Phone Number: 7743032649; Email: katherine.vlahcevic@umassmed.edu
• Study Contact Backup: Name: Arlene M Williams, RN; Phone Number: 7742897998; Email: Arlene.Williams@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Medical School
      • Contact: Ian Richmond, MD; Phone Number: 508-963-9922; Email: R.Ian.Richmond@umassmemorial.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects age 3 months to 9 years
• Scheduled to undergo a myringotomy
• American Society of Anesthesiologists (ASA) classification of I - II.

Exclusion Criteria:

• Subjects with unrepaired cardiac defects, including cyanotic congenital heart disease.
• Anyone age 10 years or older.
• Anyone with an ASA classification of III or higher.
• Non-English language speaker for whom short form consent is not available.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intra-nasal Dexmedetomidine; Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.	Drug: Intra-nasal Dexmedetomidine; Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.; Other Names: Precedex
Active Comparator: Oral Midazolam; Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.	Drug: Oral Midazolam; Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.; Other Names: Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of pediatric delirium	Time from when the patient is woken from anesthesia to the onset of delirium.	Zero minutes to 48 hours
Time to offset of pediatric delirium	Time from onset of delirium to the offset of delirium.	Zero minutes to 48 hours
Duration of pediatric delirium	Total time patient experiences delirium	Zero minutes to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug Acceptance	The willingness of the subject to take the drug was assessed in the pre-operative area	10-25 minutes prior to surgery
Parental Separation Anxiety Scale (PSAS)	Anxiety score was determined when the child was separated from the parents according to four levels.	0-48 hours
Mask Acceptance Scale	The child's acceptance of the mask by the anesthesiologist was rated as follows.	1-10 minutes prior to surgery
End tidal Sevoflurane value	During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented.	0-12 hours
Rescue analgesia in PACU	The amount and dose of oral/rectal acetaminophen given in PACU was recorded.	0-6 hours post surgery
Home Behavior Analysis	The child's parents were given a diary to document their behavior for 48 hours post-operatively at home.	12-48 hours
Oral analgesic use	Document intake of oral analgesics like acetaminophen or ibuprofen	Two days post-operative

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: R. Ian Richmond, MD, University of Massachusetts Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: H00021788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared via publication as group data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes