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Effect of Monochromatic Light on Incidence of Emergence Delirium in Children
NA trial testing Monochromatic blue light in Emergence Delirium in 104 participants. Completed in 2 June 2020.
| Lead sponsor | Baylor College of Medicine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 3 November 2017 |
| Primary completion | 30 April 2020 |
| Estimated completion | 2 June 2020 |
| Sites | 1 location across United States |
Baylor College of Medicine
Adults 2 to 6, any sex, with Emergence Delirium or Anesthesia Emergence Delirium. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)
| Group | Value | 95% CI |
|---|---|---|
| Blue Light - Non Monochromatic | 17 | |
| Monochromatic Blue Light | 3 |
Assessment of Pediatric Emergence Delirium Scale (PAED) scale scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham Pediatric Emergence Delirium Scale scored ranges from a Minimum of 2 to a maximum of 20. Higher scores are associate with emergence delirium and agitation indicating a worse outcome
| Group | Value | 95% CI |
|---|---|---|
| Blue Light - Non Monochromatic | 27 | |
| Monochromatic Blue Light | 12 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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