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

Phase 4

Completed

• Conditions: Specified Sedative; Hypnotic
• Interventions: Drug: normal saline; Drug: Diphenhydramine; Drug: Ketamine; Drug: Sevoflurane; Drug: Bupivacaine

• Registration Number: NCT02463929
• Lead Sponsor: Universitas Diponegoro

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Study First Submitted: 2015-05-18
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-02
• Last Update Submitted: 2015-06-02
• Study First Posted: 2015-06-04
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	normal saline	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
control	Bupivacaine	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
diphenhydramine	Diphenhydramine	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
diphenhydramine	Sevoflurane	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
diphenhydramine	Ketamine	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
diphenhydramine	Bupivacaine	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
control	Ketamine	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
control	Sevoflurane	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

Primary Outcome Measures

Name	Time	Method
Incidence of sevoflurane induced post anesthesia agitation	10 minutes post extubation

Secondary Outcome Measures

Name	Time	Method
Amount of rescue Ketamine used	1 minute post extubation, at emergence, 15 minute post extubation	Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated
Significant adverse events	1 minute post extubation, at emergence, 15 minute post extubation	Any respiratory or cardiovascular events during observation in recovery room
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)	15 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