Emergence Delirium, Sedation
Conditions
Keywords
dexmedetomidine, Ketamine, Nebulization, Cleft palate, Sedation, Emergence delirium
Brief summary
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Detailed description
Cleft palate is a common congenital anomaly. The American cleft palate-craniofacial Association recommends that primary cleft palate repair should be ideally performed between 12-18 months after birth. The pre-operative period is quite distressing for children due to parental separation, application of face mask for induction of anaesthesia, fear of needles and unfamiliar faces. Pre-operative Anxiety is associated with adverse outcomes via elevation of stress markers, promoting fluctuations in hemodynamic, and negatively impacting postoperative recovery. There is a growing interest in the use of dexmedetomidine, a highly selective alpha-2 adrenergic agonist, for paediatric premedication. Ketamine may attenuate dexmedetomidine-induced bradycardia and hypotension and accelerate the onset of sedation with no respiratory depression.
Interventions
DRUGNebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
DRUGNebulization of dexmedetomidine
Pre-operative nebulization of dexmedetomidine
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
No
Inclusion criteria
* Patients with American Society of Anesthesiologists (ASA) physical status I & II who will be scheduled for cleft palate repair surgeries
Exclusion criteria
* Parent refusal * Allergy to the study drugs * Suspected difficult airway * Patients with endocrine, renal, hepatic, and cardiac pathology * Psychiatric diseases * Asthmatic patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| University of Michigan Sedation Scale (UMSS) | Pre-operative | It ranges from 0 = awake, alert to 4 = unarousable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parental Separation using the Parenteral Separation Anxiety Scale (PSAS) | Pre-operative | It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome. |
| Watcha scale for emergence delirium | Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit. | It ranges from 1= calm to 4 = agitated |
Countries
Egypt
Contacts
Primary ContactFatma N. Mohamed, M.D.
Backup ContactSamar Ah. Abdellah, M.B.B.Ch.
Outcome results
None listed