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

Sponsor

Universitas Diponegoro (Other)

Overall Status

Completed

CT.gov ID

NCT02463929

Collaborator

Permata Sari Hospital for Plastic Surgery (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Specified Sedative Hypnotic	Drug: Diphenhydramine Drug: normal saline Drug: Ketamine Drug: Sevoflurane Drug: Bupivacaine	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Diphenhydramine Intravenous Injection Drug: Ketamine 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 Drug: Sevoflurane 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 Drug: Bupivacaine Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
Placebo Comparator: control 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 Intravenous Injection Other Names: NaCl 0,9% Drug: Ketamine 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 Drug: Sevoflurane 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 Drug: Bupivacaine Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.

Arm

Intervention/Treatment

Experimental: 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

Drug: Diphenhydramine

Intravenous Injection

Drug: Ketamine

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

Drug: Sevoflurane

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

Drug: Bupivacaine

Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.

Placebo Comparator: control

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

Intravenous Injection

Other Names:

NaCl 0,9%

Drug: Ketamine

Drug: Sevoflurane

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

Drug: Bupivacaine

Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.

Outcome Measures

Primary Outcome Measures

Incidence of sevoflurane induced post anesthesia agitation [10 minutes post extubation]

Secondary Outcome Measures

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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)