Effect of Different Drugs on Emergency Delirium in Preschool Age Patient

Not Applicable

Not yet recruiting

• Conditions: Emergence Delirium, Anesthesia
• Interventions: Other: 5ml of normal saline; Drug: Dexmedetomidine group (D group); Drug: Ketamine group (K group); Drug: Midazolam group (M group)

• Registration Number: NCT07057193
• Lead Sponsor: Zagazig University

Brief Summary

Emergence delirium (ED) was first described by Eckenhoff and colleagues in the 1960s and is defined in pediatric anesthesia as 'dissociated state of consciousness in which child is irritable, uncompromising, uncooperative, incoherent, and inconsolably crying, moaning, and kicking or thrashing. The commonly reported incidence of postoperative ED in pediatric patients especially with the use of sevoflurane or desflurane was from 10% to 80% during their presence in the post-anesthesia care unit. This side effect of general anesthesia causes distressing for parents and staff and may cause parental dissatisfaction with their child's care. Children during postoperative ED have the risks of injuring themselves or their caregivers, disruption of surgical repair, operative site bleeding, removing Intravenous (iv) lines or drains and increasing pain. This behavior may require more nursing supervision, overloading nursing resources. Although postoperative ED episodes are of short duration, their prevention is essential. Children experiencing postoperative ED may exhibit new-onset maladaptive behavioral abnormalities in the postoperative period such as enuresis, night-time crying, and separation anxiety, up to 14 days post-surgery.

The risk factors to postoperative ED are patients' characters (preschool age and preexisting behavior), the surrounding environment as parental anxiety, type of anesthesia (volatile anesthetics) as sevoflurane or halothane and the type of surgery as tonsillectomy, adenoidectomy, and strabismus surgery which is one of the most commonly undertaken surgeries in pediatric patients. It may cause visual disturbance in the recovery phase, which can result. In order to diagnose ED, the presence of pain during recovery from general anesthesia must be ruled out because it leads to a change in behavior that resembles delirium. Fortunately, one of the advantages of using the Pediatric Anesthesia Emergence Delirium (PAED) scale is its ability to distinguish between the ED and the change in behavior resulting from pain, because it focuses on changes in awareness and knowledge that are not changed by pain. Prophylactic drugs against the occurrence of postoperative ED include the adjuvant use of α2 adrenoreceptor agonists such as dexmedetomidine, ketamine, midazolam, propofol, and fentanyl. The use of these drugs with them adverse effects should be weighed against the fact that postoperative ED is a self-limited disorder. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that is associated with sedative and analgesic sparing effects. It is commonly used for prevention of emergence delirium and agitation, perioperative sympatholysis, cardiovascular stabilization, and preservation of respiratory function. Ketamine is a dissociative anesthetic. Its mechanism of action is mainly via a noncompetitive antagonism of the N - methyl - D - aspartic acid (NMDA) receptor. It also targets other receptors, such as a - amino - 3 - hydroxy - 5 - methyl - 4 - isoxazolepropionic acid (AMPA) receptors, and has additional acts as an agonist of the sigma 1 receptor. It is commonly used for acute pain management, chronic pain management, prevention of ED, and postoperative nausea and vomiting. Midazolam is short acting benzodiazepine which is central nervous system depressant. It is commonly used for premedication during pediatric anesthesia, for prevention of emotional distress and ED due to its sedative and anxiolytic properties, additionally it used for reduction of the analgesic requirement and to prevent postoperative nausea and vomiting

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-26
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-06
• Study First Posted: 2025-07-09
• Last Update Submitted: 2025-07-10
• Study Start: 2025-07-15
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Parents or first degree relative acceptance. - Age: 3-5 years old. - Body weight: 5% -85% of BMI (kg /m2) of the same age and sex. - Sex: Both sexes. - Physical Status: Of class I and II according to American Society of Anesthesiologists (ASA) classification. - Type of surgery: Squint surgeries under sevoflurane anesthesia.

Exclusion Criteria

• • Children with score 3 (i.e. anxious and crying) according to the three-point anxiety scale (Kain et al. 2004). - Children with preexisting abnormal behavior, psychiatric disorders, developmental delay or central nervous system diseases (epilepsy). - Children with chronic use of sedative drugs. - Children with severe respira

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (C group)	5ml of normal saline	patients will receive 5ml of normal saline intravenous10 min before the end of the surgical procedure as placebo.
Dexmedetomidine group (D group)	Dexmedetomidine group (D group)	patients will receive intravenous dexmedetomidine (0.25 μg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Ketamine group (K group)	Ketamine group (K group)	patients will receive intravenous ketamine (0.25mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.
Midazolam group (M group)	Midazolam group (M group)	patients will receive intravenous midazolam (0.05 mg/kg diluted with normal saline to a volume of 5 ml solution) 10 min before the end of the surgical procedure.

Primary Outcome Measures

Name	Time	Method
the incidence and severity of ED using the Pediatric Anesthesia Emergence Scale (PAED) Scale.	preoperative, baseline, PACU, 10, 20, 30 mins postoperative , perioperative	the incidence and severity of ED using the Pediatric Anesthesia Emergence Scale (PAED) Scale.

Secondary Outcome Measures

Name	Time	Method
recovery time. postoperative pain severity	preoperative as baseline and upon arrival to PACU, then 10, 20, and 30 minutes after admission, perioperative	Recovery time. IV. Post operative pain severity: will be assessed upon arrival to PACU, then at 10, 20, 30 min, and finally upon discharge from it. V. Hemodynamic and SpO2 changes: MAP, HR, and SpO2 will be measured the night before surgery as baseline, then intraoperative immediately before and at 5, 10, 20, 30 min after study drug administration. In the PACU, these parameters will be recorded upon arrival to PACU and then at 10, 20 min and finally upon discharge from PACU. VI. Time to discharge from PACU. VII. The degree of parents' satisfaction. VIII. The associated side effects: such as bradycardia, hypotension, peripheral blood oxygen desaturation vomiting, and allergy to the study drugs