Clinical trial NCT05874245: Effect of Oral Dexmedetomidine, Ketamine, Or Midazolam as Preioperative Medications.
Official title: PERIOPERATIVE EFFECTS OF ORAL DEXMEDETOMIDINE, KETAMINE, OR MIDAZOLAM PREMEDICATION IN CHILDREN UNDERGOING ADENOTONSILLECTOMY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 222
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a prospective randomized double-blind study. Patients will be randomized into three groups using a closed envelope technique in sequentially numbered opaque envelopes that will be opened by an anesthesiologist not involved in the study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.

In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.

Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.

An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents. \[5\]

Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.

Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, antiemesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.

Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.

An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication.

Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.

Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.

Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.

Detailed description: Anxiety preceding surgery results in hemodynamic instability, metabolic side effects, increased post-operative pain, and agitation during emergence. Therefore, pharmacological interventions are used to reduce pre-operative anxiety and enhance anesthetic induction without delaying recovery. The premedication must be administered in a manner that is safe, painless, and without significant adverse effects.

In children, the incidence of emergency agitation or delirium after general anesthesia ranges from 10% to 80% and significantly increases the incidence of other complications after anesthesia, such as self-injury, prolonged postanesthesia care unit (PACU) stay, frustration of parents and care providers.

Numerous pharmacological and non-pharmacological techniques, including sedative premedication, parental presence, and training programs for participants and their parents, have been investigated to reduce anxiety and enhance compliance during anesthesia induction.

An ideal premedication prescription should sedate a child to facilitate separation from parents, thus simplifying anesthesia induction and creating a pleasant surgical experience for both children and parents.

Anxiolysis is the major objective of premedication in children, as it facilitates separation from parents and facilitates the induction of anesthesia.

Premedication may also induce amnesia, the prevention of physiologic stress, vagolysis, a decrease in total anesthetic requirements, a lower likelihood of aspiration, decreased salivation and secretions, anti-emesis, and analgesia. All drugs have the potential to make people sleepy and slow their breathing, so they must be given with extreme care and closely watched.

Ketamine is a useful sedative and analgesic for preventing preoperative anxiety in children; it exerts its analgesic effect through the reversible antagonist action of N-methyl-D-aspartate receptors. It has analgesic and sedative effects in different doses of administration. Ketamine is often administered orally and is αreported to be safe and effective in pediatric patients.

An effective sedative and analgesic with minimal respiratory depressive effects is dexmedetomidine, an α2-adrenoceptor agonist. It also reduces the hemodynamic stress response due to its sympatholytic effect. These characteristics make it a possible anesthetic premedication. Midazolam, a water-soluble benzodiazepine, is commonly used as a preanesthetic medicine in children due to its several favorable effects: sedation, anxiolysis, antegrade amnesia, rapid onset, and brief duration of action.

Adenoidectomy and/or tonsillectomy are the most common surgical procedures done on children.

Hence, the present study will be conducted to objectively evaluate, the perioperative effects of oral dexmedetomidine, ketamine, or midazolam premedication in patients undergoing adenotonsillectomy.

Eligibility criteria: Inclusion Criteria:

* All patients within the age range of 3 to 8 years old.
* Elective non complicated adenotonsillectomy.
* ASA I or II physical status.

Exclusion Criteria:

* Refusal of the patient's parents or legal guardians to give informed consent.
* History of allergy to any of the study drugs.
* Preoperative intake of opioid or non-steroidal anti-inflammatory drugs within 24 h before surgery.
* Neurological and/or psychological diseases.
* Associated cardio-respiratory illness

Primary outcomes:
measure: measure sedative effectes of Dexmedetomidine, Ketamine, or Midazolam using modified observer's assessment of alertness/sedation scale and parental separation anxiety scale.
timeFrame: 12 months
Secondary outcomes:
measure: Amount of analgesia required postperative by Face, Legs, Activity, Cry, Consolability (FLACC) Behavioural Pain Scale.
timeFrame: 12 months
measure: Measure Emergence agitation by Richmond Agitation-Sedation Scale (RASS)
timeFrame: 12 months
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia university hospitails
state: Menoufia
Study officials:
References: