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Pediatric Delirium

Primary Purpose

Pediatric Delirium

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intra-nasal Dexmedetomidine
Oral Midazolam
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pediatric Delirium

Eligibility Criteria

3 Months - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Massachusetts Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intra-nasal Dexmedetomidine

Oral Midazolam

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to onset of pediatric delirium
Time from when the patient is woken from anesthesia to the onset of delirium.
Time to offset of pediatric delirium
Time from onset of delirium to the offset of delirium.
Duration of pediatric delirium
Total time patient experiences delirium

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2020
Last Updated
May 25, 2023
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT04669457
Brief Title
Pediatric Delirium
Official Title
Prevention of Emergence Delirium in Pediatric Ambulatory Surgery: Single Blinded Randomized Control Study Comparing Intra-nasal Dexmedetomidine With Oral Midazolam.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
Care ProviderOutcomes Assessor
Masking Description
The surgeon and post-operative nurses will be masked to the group allocation. Masking will only be revealed if medically necessary.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-nasal Dexmedetomidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral Midazolam
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intra-nasal Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Midazolam
Other Intervention Name(s)
Midazolam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to onset of pediatric delirium
Description
Time from when the patient is woken from anesthesia to the onset of delirium.
Time Frame
Zero minutes to 48 hours
Title
Time to offset of pediatric delirium
Description
Time from onset of delirium to the offset of delirium.
Time Frame
Zero minutes to 48 hours
Title
Duration of pediatric delirium
Description
Total time patient experiences delirium
Time Frame
Zero minutes to 48 hours
Secondary Outcome Measure Information:
Title
Drug Acceptance
Description
The willingness of the subject to take the drug was assessed in the pre-operative area
Time Frame
10-25 minutes prior to surgery
Title
Parental Separation Anxiety Scale (PSAS)
Description
Anxiety score was determined when the child was separated from the parents according to four levels.
Time Frame
0-48 hours
Title
Mask Acceptance Scale
Description
The child's acceptance of the mask by the anesthesiologist was rated as follows.
Time Frame
1-10 minutes prior to surgery
Title
End tidal Sevoflurane value
Description
During the surgery and at the time when patient leaves the OR End tidal Sevoflurane value will be documented.
Time Frame
0-12 hours
Title
Rescue analgesia in PACU
Description
The amount and dose of oral/rectal acetaminophen given in PACU was recorded.
Time Frame
0-6 hours post surgery
Title
Home Behavior Analysis
Description
The child's parents were given a diary to document their behavior for 48 hours post-operatively at home.
Time Frame
12-48 hours
Title
Oral analgesic use
Description
Document intake of oral analgesics like acetaminophen or ibuprofen
Time Frame
Two days post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Vlahcevic
Phone
7743032649
Email
katherine.vlahcevic@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Arlene M Williams, RN
Phone
7742897998
Email
Arlene.Williams@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Ian Richmond, MD
Organizational Affiliation
University of Massachusetts Chan Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Richmond, MD
Phone
508-963-9922
Email
R.Ian.Richmond@umassmemorial.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared via publication as group data.

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Pediatric Delirium

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