Clinical TrialKetamineCompleted
Intranasal dexmedetomidine versus intranasal ketamine for prevention of emergence agitation after sevoflurane anesthesia in pediatric patients undergoing myringotomy : a randomized clinical trial.
This randomised controlled trial (n=90) evaluated the safety and efficacy of ketamine for emergence agitation after sevoflurane anesthesia in children using 350mg/70kg ketamine.
Target Enrollment
90 participants
Study Type
interventional
Design
Randomized
Registry
Detailed Description
The aim of this prospective randomized study is to compare the effect of intranasal dexmedetomidine and intranasal ketamine for prevention of emergence agitation after sevoflurane anesthesia in pediatric patients scheduled for myringotomy operations.
Study Arms & Interventions
Experimental Arm
experimentalInterventions
- Ketamine
Participants
Inclusion Criteria
- Patients prepared to unilateral or bilateral myringotomy
- Both sexes, age from 3 to 6 years old.
- ASA physical status I or II.
Exclusion Criteria
- a -Parent's refusal.
- b- Preoperative agitation (e.g. cerebral palsy, agitation…etc).
- c - Children with allergy to ketamine, dexmedetomidine.
- d - Aberrant nasal deformity or nasal trauma.
- e - Acute (e.g. running nose or upper respiratory tract infection) or chronic nasal problems.
- f -Mental retardation, physical developmental delay, or neuromuscular disease.
- g - Patients under treatment with sedatives or anticonvulsants.
- h - Respiratory and cardiovascular diseases.
Study Details
- StatusCompleted
- Typeinterventional
- DesignRandomized
- Target Enrollment90 participants
- TimelineStart: 2016-02-02End: 2016-05-26
- Compound
Locations
Unknown facility — Australia