Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Assiut University

Status and phase: Enrolling; Phase 4

Conditions: Emergence Delirium; Sedation

Treatments: Drug: Nebulization of dexmedetomidine; Drug: Nebulization of dexmedetomidine and ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT05821972

Dexmedetomidine Ketamine

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 48 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Nebulized dexmedetomidine and ketamine

Experimental group

Description:

Pre-operative nebulization of dexmedetomidine and ketamine

Treatment:

Drug: Nebulization of dexmedetomidine and ketamine

Nebulized dexmedetomidine

Active Comparator group

Description:

Pre-operative nebulization of dexmedetomidine

Treatment:

Drug: Nebulization of dexmedetomidine