Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric

Conditions
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Specified Sedative, Hypnotic

Intervention / Treatment
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* Drug: Diphenhydramine
* Drug: normal saline
* Drug: Ketamine
* Drug: Sevoflurane
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I or 2 no cardiovascular, respiratory or neurologic congenital anomalies no allergic reactions, or any contraindication to drugs used in this trial ever documented Exclusion Criteria: congenital anomalies recognized/diagnosed during trial procedures hemmorhage > 15% EBV shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ETT or IV line)

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diphenhydramine<br>Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered | Drug: Diphenhydramine<br>* Intravenous Injection<br>Drug: Ketamine<br>* 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<br>Drug: Sevoflurane<br>* 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<br>Drug: Bupivacaine<br>* Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.<br>|
| Placebo Comparator: control<br>Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered | Drug: normal saline<br>* Intravenous Injection<br>* Other names: NaCl 0,9%;Drug: Ketamine<br>* 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<br>Drug: Sevoflurane<br>* 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<br>Drug: Bupivacaine<br>* Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sevoflurane induced post anesthesia agitation |  | 10 minutes post extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of rescue Ketamine used | Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated | 1 minute post extubation, at emergence, 15 minute post extubation | 
| Significant adverse events | Any respiratory or cardiovascular events during observation in recovery room | 1 minute post extubation, at emergence, 15 minute post extubation | 
| Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) |  | 1 minute post extubation | 
| Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) |  | at emergence | 
| Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) |  | 15 minute post extubation | 
| Incidence of sevoflurane induced post anesthesia agitation |  | 1 minute post extubation | 
| Incidence of sevoflurane induced post anesthesia agitation |  | 15 minute post extubation | 
| Length of stay in recovery room |  | up to 15 minutes post extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphenhydramine, emergence agitation, pediatric anesthesia, PAEDS, Withdrawal