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

Universitas Diponegoro

Status and phase: Completed; Phase 4

Conditions: Hypnotic; Specified Sedative

Treatments: Drug: Sevoflurane; Drug: Diphenhydramine; Drug: normal saline; Drug: Bupivacaine; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02463929

UDiponegoro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 2 to 24 months old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

diphenhydramine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: Sevoflurane

Drug: Diphenhydramine

Drug: Ketamine

control

Placebo Comparator group

Description:

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

Treatment:

Drug: Bupivacaine

Drug: Sevoflurane

Drug: Ketamine

Drug: normal saline