Pediatric Delirium

Pediatric Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04669457
• Other study ID #: H00021788
• Status: Recruiting
• Phase: Phase 4
• Start date: April 27, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University of Massachusetts, Worcester
• Contact: Katherine Vlahcevic
• Phone: 7743032649
• Email: katherine.vlahcevic[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Pediatric Delirium

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to offset of pediatric delirium	Time from onset of delirium to the offset of delirium.	Zero minutes to 48 hours
Primary	Duration of pediatric delirium	Total time patient experiences delirium	Zero minutes to 48 hours
Secondary	Drug Acceptance	The willingness of the subject to take the drug was assessed in the pre-operative area	10-25 minutes prior to surgery
Secondary	Parental Separation Anxiety Scale (PSAS)	Anxiety score was determined when the child was separated from the parents according to four levels.	0-48 hours
Secondary	Mask Acceptance Scale	The child's acceptance of the mask by the anesthesiologist was rated as follows.	1-10 minutes prior to surgery
Secondary	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
Secondary	Rescue analgesia in PACU	The amount and dose of oral/rectal acetaminophen given in PACU was recorded.	0-6 hours post surgery
Secondary	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
Secondary	Oral analgesic use	Document intake of oral analgesics like acetaminophen or ibuprofen	Two days post-operative