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N/A N=104 Randomized Double-blind Treatment

Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Emergence Delirium · Anesthesia Emergence Delirium

Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Emergence Delirium Following Anesthesia in Children — 17; 3 Participants — p=0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Monochromatic blue light (Device)
Age
Pediatric · 2+ yrs
Sex
All
Sponsor
Baylor College of Medicine
Primary completion
Apr 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Emergence Delirium Following Anesthesia in Children
17; 3 0.001 sig
SECONDARY
Number of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline
27; 12 0.002 sig

Summary

Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology consisting of short lived behavioral changes that can be both traumatic to families and pose a safety risk to patients and staff. ED is characterized by a variety of presentations, including crying, excitation and agitation, that occur during the early stage of recovery from general anesthesia, generally in the first 30 minutes. Emergence delirium occurs in children of all ages following an anesthetic with halogenated agents (e.g. sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI patients). Presently, the treatment for ED is to revert the patient back to a hypnotic state mainly with sedatives so that they may "reset" themselves postulating that by re-inducing a hypnotic state, the brain has time to resolve this issue. The hypothesis of this study is that during ED, there is failure of organized EEG activity, especially alpha wave activity and that by enhancing alpha activity, the incidence of ED may be reduced without the need for additional pharmaceuticals which may be costly, delay recovery and are not without adverse effects specifically cardiopulmonary depression through the use of blue monochromatic light.

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologist Classification of 1,2
  • Patients ages 2-6 years
  • Routine tonsillectomy and adenoidectomy

Exclusion Criteria

American Society of Anesthesiology classification other than 1,2; history of migraine headaches; ocular disorders; seizure history; psychiatric conditions; anxiety; parental refusal; developmental delay; patients on medication for attention deficit disorders or caffeine stimulants; Patients with contraindications to receiving inhalation agents; Use of premedication with midazolam or dexmedetomidine;

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03285243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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