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

Ketamine

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.

Intervention / Treatment

  • Diphenhydramine (DRUG)
    Intravenous Injection
  • Normal saline (DRUG)
    Intravenous Injection
  • Ketamine (DRUG)
    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
  • Sevoflurane (DRUG)
    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
  • Bupivacaine (DRUG)
    Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.

Condition or Disease

  • Specified Sedative
  • Hypnotic

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Months to 24 Months
    Enrollment: 50 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Apr 01, 2014
    Primary Completion: Jun 01, 2014 ACTUAL
    Completion Date: Jul 01, 2014 ACTUAL
    Study First Posted: Jun 04, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jun 02, 2015

    Sponsors / Collaborators

    Lead Sponsor: Universitas Diponegoro
    Responsible Party: N/A

    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.

    Participant Groups

    • 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

    • 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

    Eligibility Criteria

    Sex: All
    Maximum Age: 2
    Age Groups: Child
    Healthy Volunteers: Yes

    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)

    Primary Outcomes
    • Incidence of sevoflurane induced post anesthesia agitation 10 minutes post extubation
    Secondary Outcomes

    • Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated

    • 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

    More Details

    NCT Number: NCT02463929
    Other IDs: UDiponegoro
    Study URL: https://clinicaltrials.gov/study/NCT02463929
    Last updated: Sep 29, 2023