Emergence Delirium
Conditions
Keywords
Anesthesia, Melatonin, Sevoflurane, Postoperative Pain, Child, PONV
Brief summary
Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.
Interventions
DRUGMelatonin
Melatonin for injection 1 mg/mL
Sodium chloride 0.9 % for injection
Sponsors
Sygehus Lillebaelt
University of Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 1-6 years * Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane
Exclusion criteria
* Any known allergy or contraindication to study treatment or excipåients * Current daily medication with melatonin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence agitation | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | Participants will be assessed on Watcha scale repeatedly ever 15 min during their stay at the Post-Anesthetic Care Unit. The variable is dichotomous: any score \>2= Yes and no score \<=2 = No |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | The total amount of opioids administered for postoperative pain in the PACU will be evaluated as units of morphine equivalents per kg. No more than 35 % of the popu-lation is expected to receive postoperative opioids in a range of approximately 10-100 µg/kg. |
| Non-serious Adverse Events (AE) | From enrolment to the trial until 24-hour follow-up. | Any untoward medical occurrence not considered serious. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to administration of opioid | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | Time from end of anesthesia to the time point at which the first dose of opioid is administered in PACU. Not all participants (expectedly up to approximately 35%) will receive opioids in PACU. |
| Need for rescue medication | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | Dichotomous assessment of any administration in PACU of rescue medication specifically targeting EA according to treatment algorithm i.e., clonidine or propofol. |
| Time to awakening in PACU | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | Time from end of anesthesia to the first time point at which the participant is awake. If the participant is not awake two hours after arrival in PACU, a wake-up at-tempt will be carried out. |
| Serious Adverse Events (SAE) | SAEs will be assessed from enrolment until 30 days after intervention. | We will use the International Conference on Harmonization of technical require-ments for registration of pharmaceuticals for human use-Good Clinical Practice (ICH-GCP) definition of a serious adverse event, which is any untoward medical occurrence that resulted in death, was life-threatening, re-quired hospitalization or prolonging of existing hospitalization and resulted in persistent or significant disability or jeopardized the participant. |
| Time for discharge readiness | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | Time from end of anesthesia (defined as above) to the time point at which partici-pant fulfills local discharge criteria. Discharge criteria will be evaluated by the re-sponsible physician prior to final discharge from PACU either to the participant's ward or to their home. |
| Emergence delirium | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | The incidence of emergence delirium will be evaluated according to the PAED score assessed every 15 minutes during PACU stay. The end-point is defined dichotomously as any score ≥10. Due to feasibility concerns, this outcome will solely be evaluated in a sub-population of approximately 50% of the trial population (200 participants), specifically only thos enrolled at the Juliane Marie Center Site. |
| Readmissions within 30 days | From day of discharge + 30 days. | Assessed dichotomously counting day 0 as the day of discharge from hospital after the procedure. For the small group (expectedly \<5 %) who will have had any read-missions within 30 days, the number of readmissions will be described. |
| Time to postoperative oral intake | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | Time from end of anesthesia to the first time point at which the participant eats/drinks. All participants are assumed to eat/drink during their PACU stay. |
| Postoperative pain | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | The incidence of postoperative pain will be assessed in each group according to the FLACC scale, assessed every 15 minutes in PACU. Postoperative pain is defined as any FLACC score \>3. |
| Postoperative nausea and vomiting (PONV) | Up to approximately 4 hours corresponding to stay in Post-Anesthetic Care Unit (PACU). | The incidence of PONV will be assessed dichotomously every 15 minutes in PACU. Outcome assessors will observe for vomiting. Nausea can be considered present if the participant refuses to eat and other causes are ruled out. There is no adequate PONV assessment tool available. PONV will be considered present if any assess-ment during PACU stay is Yes. |
Countries
Denmark
Contacts
Primary ContactAnne Louise B Garioud, MD
Outcome results
None listed