Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05821972

Collaborator

(none)

Enrollment

Location

Arms

15.6

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sedation Emergence Delirium	Drug: Nebulization of dexmedetomidine and ketamine Drug: Nebulization of dexmedetomidine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nebulized dexmedetomidine and ketamine Pre-operative nebulization of dexmedetomidine and ketamine	Drug: Nebulization of dexmedetomidine and ketamine Pre-operative nebulization of dexmedetomidine and ketamine
Active Comparator: Nebulized dexmedetomidine Pre-operative nebulization of dexmedetomidine	Drug: Nebulization of dexmedetomidine Pre-operative nebulization of dexmedetomidine

Arm

Intervention/Treatment

Experimental: Nebulized dexmedetomidine and ketamine

Pre-operative nebulization of dexmedetomidine and ketamine

Drug: Nebulization of dexmedetomidine and ketamine

Pre-operative nebulization of dexmedetomidine and ketamine

Active Comparator: Nebulized dexmedetomidine

Pre-operative nebulization of dexmedetomidine

Drug: Nebulization of dexmedetomidine

Pre-operative nebulization of dexmedetomidine

Outcome Measures

Primary Outcome Measures

Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) [Pre-operative]
It ranges from 0 = does not respond to a noxious stimulus, to 6 = Appears alert and awake and responds readily to name spoken in normal tone. the higher scores mean less sedation.

Secondary Outcome Measures

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.
Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale [Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.]
It ranges from 0 to 20. PAED score > 12 indicates the presence of emergence delirium with high sensitivity and specificity.