Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Sedation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821972
• Other study ID #: Dexmedetomidine Ketamine
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 15, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Fatma N. Mohamed, M.D.
• Phone: +201003633992
• Email: fatmanabil2012[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 48 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate
• Delirium
• Emergence Delirium
• Sedation

Intervention

Drug:
• Nebulization of dexmedetomidine and ketamine
Pre-operative nebulization of dexmedetomidine and ketamine
• Nebulization of dexmedetomidine
Pre-operative nebulization of dexmedetomidine

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation level using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S)	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.	Pre-operative
Secondary	Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)	It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.	Pre-operative
Secondary	Emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) scale	It ranges from 0 to 20. PAED score > 12 indicates the presence of emergence delirium with high sensitivity and specificity.	Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.