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NCT Number: NCT07057193

Effect of Different Drugs on Emergency Delirium in Preschool Age Patient

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine group (D group)

Drug

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)

Drug

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)

Drug

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.

5ml of normal saline

Other

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

Primary outcomes

  1. the incidence and severity of ED using the Pediatric Anesthesia Emergence Scale (PAED) Scale.

    Time frame: preoperative, baseline, PACU, 10, 20, 30 mins postoperative , perioperative

    the incidence and severity of ED using the Pediatric Anesthesia Emergence Scale (PAED) Scale.

Secondary outcomes

  1. recovery time. postoperative pain severity

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

asmaa galal el din, lecture of anesthesia

CONTACT

[email protected]

+201271550089

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Effect of Dexmedetomidine, Ketamine or Midazolam on the Incidence and Severity of Emergence Delirium in Preschool-Aged Children Following Squint Surgeries Under Sevoflurane Anesthesia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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