Effect of Different Drugs on Emergency Delirium in Preschool Age Patient

Zagazig University

Status: Not yet enrolling

Conditions: Emergence Delirium, Anesthesia

Treatments: Drug: Ketamine group (K group); Drug: Dexmedetomidine group (D group); Drug: Midazolam group (M group); Other: 5ml of normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07057193

Zagazig S

Details and patient eligibility

About

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

Enrollment: 92 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 4 patient groups, including a placebo group

Control group (C group)

Placebo Comparator group

Description:

patients will receive 5ml of normal saline intravenous10 min before the end of the surgical procedure as placebo.

Treatment:

Other: 5ml of normal saline

Dexmedetomidine group (D group)

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine group (D group)

Ketamine group (K group)

Active Comparator group

Description:

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.

Treatment:

Drug: Ketamine group (K group)

Midazolam group (M group)

Active Comparator group

Description:

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.

Treatment:

Drug: Midazolam group (M group)