diphenhydramine
DrugIntravenous Injection
NCT Number: NCT02463929
The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.
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Notify Me2 month–24 month
All sexes
Interventional
Phase 4
This is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. Subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. Agitation or emergence delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas feasability to return to the ward scored with the Steward score. When PAEDS> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
ASA I or 2
Exclusion criteria
Intravenous Injection
Intravenous Injection
Other names: NaCl 0,9%
Ketamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation
Sevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent
Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
Time frame: 10 minutes post extubation
Time frame: 1 minute post extubation, at emergence, 15 minute post extubation
Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated
Time frame: 1 minute post extubation, at emergence, 15 minute post extubation
Any respiratory or cardiovascular events during observation in recovery room
Time frame: 1 minute post extubation
Time frame: at emergence
Time frame: 15 minute post extubation
Time frame: 1 minute post extubation
Time frame: 15 minute post extubation
Time frame: up to 15 minutes post extubation
Universitas Diponegoro
Other
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