Adenotonsillectomy, Emergence Agitation, Lactium
Conditions
Brief summary
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.
Detailed description
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 .
Interventions
DRUGLactium
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.
OTHERPlacebo control
50 ml water added to it powdered vanilla flavor will be given to cases 2 hours before surgery.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Both gender * 4 to 7 years age * American Society of Anesthesiologists (ASA) Physical Status I or II * Scheduled for adenotonsillectomy surgery under sevoflurane anesthesia
Exclusion criteria
* Parents declined to participate in the trial * Children with behavioral changes; neurological or psychiatric diseases * Physical or developmental delay * Sedative or anticonvulsant medication * Pre-existing renal or cardiovascular disease, bone disease, or gastrointestinal disorders * • History of lactose intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence agitation | Up to 1 hour after surgery. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mask Acceptance Score | Perioperative | 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 |
| Postoperative pain | Up to 1 hour after surgery. | 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. |
| Parental separation anxiety | Perioperative | 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 |
| Pediatric Anesthesia Emergence Delirium scale scores | Up to 1 hour after surgery. | severity of agitation will be assessed by Pediatric Anesthesia Emergence Delirium scale. |
| Number of patients who will develop postoperative nausea and vomiting. | Up to 2 hours after surgery. | Any episodes of nausea and vomiting will be recorded. |
| Total dose of rescue fentanyl | Up to 1 hour after surgery. | Fentanyl will be given for agitation or pain |
Countries
Egypt
Outcome results
None listed