Nebulized Versus Intravenous Dexmedetomidine for Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy

Assiut University

Status: Enrolling

Conditions: Emergence Agitation

Treatments: Drug: Nebulized Dexmedetomidine; Drug: Intravenous Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05641376

60757593

Details and patient eligibility

About

Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA I and II
• Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.

Exclusion criteria

• Patient's guardian refusal to participate in the study.
• Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
• Children on sedative or anticonvulsant medication.
• history of sleep apnea
• significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
• Known allergy to the study drugs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Nebulized Dexmedetomidine

Active Comparator group

Description:

Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.

Treatment:

Drug: Nebulized Dexmedetomidine

Intravenous Dexmedetomidine

Active Comparator group

Description:

Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.

Treatment:

Drug: Intravenous Dexmedetomidine