Hypnotic, Specified Sedative
Conditions
Keywords
Diphenhydramine, emergence agitation, pediatric anesthesia, PAEDS, Withdrawal
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.
Interventions
DRUGDiphenhydramine
Intravenous Injection
DRUGnormal saline
Intravenous Injection
DRUGKetamine
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
DRUGSevoflurane
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
DRUGBupivacaine
Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
Sponsors
Permata Sari Hospital for Plastic Surgery
Universitas Diponegoro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of sevoflurane induced post anesthesia agitation | 10 minutes post extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incidence of sevoflurane induced post anesthesia agitation | 1 minute post extubation | — |
| Length of stay in recovery room | up to 15 minutes post extubation | — |
Outcome results
None listed