This prospective randomized controlled study will be conducted to evaluate the effects of preoperative lactium on the incidence and severity of emergence agitation in children undergoing adenotonsillectomy using sevoflurane anesthesia.
Emergence agitation is a frequent postoperative complication in pediatric patients receiving inhalational anesthetics with a rapid recovery profile, e.g. sevoflurane. There is a wide variation in the reported incidence, with estimates ranging from 30% to 80%, depending on the definition, assessment tool and time frame of monitoring in the recovery period. Lactium is a synthetic derivative of alpha-s1 casein hydrolysate (ACH) containing the alpha-casozepine peptide, which is one of the main components of milk protein. It contains benzodiazepine-like α-casozepine, which has been shown to interact with gamma-aminobutyric acid receptors to provide anxiolytic and anti-stress effects. In this novel study, we hypothesize that the pre-emptive administration of Lactium may decrease emergence agitation incidence in children undergoing adenotonsillectomy. Given the fact that preoperative anxiety and parent separation are predictors for emergence agitation , the efficacy of Lactium in alleviating stress-related symptoms, that may be obtained before anesthetic induction may explain its prophylactic benefit against emergence agitation .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
135
Lentra sachet (containing 150 mg Lactium) will be totally dissolved in 100 ml water and 50 ml will be given to cases, 2 hours before surgery.
50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery.
Tanta University
Tanta, Gharbia Governorate, Egypt
Incidence of emergence agitation
Pediatric Anesthesia Emergence Delirium scale scores will be used and a score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation. It will be assessed on arrival to the post anesthesia care unit (PACU), and every 15 min thereafter for 1 hour
Time frame: Up to 1 hour after surgery.
Parental separation anxiety
It will be assessed at the time of taking the child to the operating theater by the attending anesthesiologist using the Parent Separation Anxiety Scale. It ranges from one to four where one refers to easy separation; two equals whimpers; three denotes that the child cries and cannot be easily reassured, but not clinging to parents; and 4 signifies crying and clinging to parents. A score of 1 or 2 will be considered as 'acceptable' separation
Time frame: Perioperative
Mask Acceptance Score
Ease of mask acceptance will be graded using the Mask Acceptance Score. It is a 4-point scale: 1 = excellent (unafraid, accepts mask readily); 2 = good (slight fear of mask, easily reassured); 3 = fair (moderate fear of mask, not calmed with reassurance); and 4 = poor (terrified, combative and crying). A score of 1 or 2 will be considered 'satisfactory' mask acceptance
Time frame: Perioperative
Postoperative pain
the Face, Legs, Activity, Cry and Consolability (FLACC) scale will assess the pain degree at PACU arrival and every 0.25 hour for 1 hour after surgery. A FLACC score of at least 4 will be treated with 0.5mcg/kg of IV fentanyl.
Time frame: Up to 1 hour after surgery.
Total dose of rescue fentanyl
Fentanyl will be given for agitation or pain
Time frame: Up to 1 hour after surgery.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pediatric Anesthesia Emergence Delirium scale scores
severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale.
Time frame: Up to 1 hour after surgery.
Number of patients who will develop postoperative nausea and vomiting.
Any episodes of nausea and vomiting will be recorded.
Time frame: Up to 2 hours after surgery.