Skip to content

Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient

Effect of Fixed Dose Intravenous Dexmedetomidine on Emergence Delirium After General Anesthesia for a Surgery in Pediatric Patient

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05813106
Enrollment
60
Registered
2023-04-14
Start date
2022-12-01
Completion date
2023-04-30
Last updated
2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmeditomidine, Emergence Delirium

Keywords

emergence delirium, dexmeditomidine, pediatric patients

Brief summary

Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.

Detailed description

Emergence delirium (ED) is an altered state of consciousness that usually occurs within 45 minutes after cessation of anesthesia. It typically presents as disorientation, averted eyes or staring, psychomotor agitation and non-purposeful, resistive movements like pulling, kicking or flailing (1, 2). ED can result in potential risk of bodily harm to patient or healthcare staffs, prolonged PACU (post-anesthesia care unit) stay and postoperative maladaptive changes including temper tantrums, attention seeking, sleep alterations and bed wetting in children (2). Risk factors for ED include preoperative anxiety and confusion, psychological immaturity and use of various medications peri-operatively (2, 3). The incidence of ED varies by age of patient, anesthesia technique, type of surgeries, pain and also by choice of tool to diagnose ED. It occurs two to three more commonly in children as compared to adults. Scientific literature suggest the incidence of ED in the range between 20 -80 % in pediatric anesthesia practice (4). Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.

Interventions

DRUGDexmedetomidine Hydrochloride

Intravenous dexmedetomidine 0.2 mcg/kg

DRUGnormal saline

normal saline

Sponsors

Security Forces Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

2 groups One group will receive IV dexmedetomidine Other control group receive normal saline

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged between 2 and 12 years, scheduled to undergo general anesthesia for a surgery with an ASA score of 1 to 3 will be included in the study.

Exclusion criteria

* Parents who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with known allergy to dexmedetomidine, psychiatric disorders or use of psychiatric medications will not be included in the study

Design outcomes

Primary

MeasureTime frameDescription
Emergence deliriumup to 120 minutesEmergence delirium will be measured using PAED score

Secondary

MeasureTime frameDescription
Pain scoreevery 15 minutes upto discharge from PACU maximum 120 minutesVAS pain score
Opioid consumptionupto discharge from PACU maximum 120 minutesMorphine equivalent opioid consumption
Side effectsPACU stay maximum 120 minutesSide effects including PONV, drowsiness

Countries

Saudi Arabia

Contacts

Primary ContactAnwar ul Huda, FRCA
hudaanwar90@yahoo.com00966118024331

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026