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

Primary Purpose

Specified Sedative, Hypnotic

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diphenhydramine
normal saline
Ketamine
Sevoflurane
Bupivacaine
Sponsored by
Universitas Diponegoro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Specified Sedative focused on measuring Diphenhydramine, emergence agitation, pediatric anesthesia, PAEDS, Withdrawal

Eligibility Criteria

2 Months - 24 Months (Child)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    diphenhydramine

    control

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

    Incidence of sevoflurane induced post anesthesia agitation

    Secondary Outcome Measures

    Amount of rescue Ketamine used
    Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated
    Significant adverse events
    Any respiratory or cardiovascular events during observation in recovery room
    Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    Incidence of sevoflurane induced post anesthesia agitation
    Incidence of sevoflurane induced post anesthesia agitation
    Length of stay in recovery room

    Full Information

    First Posted
    May 18, 2015
    Last Updated
    June 2, 2015
    Sponsor
    Universitas Diponegoro
    Collaborators
    Permata Sari Hospital for Plastic Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02463929
    Brief Title
    Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
    Official Title
    Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitas Diponegoro
    Collaborators
    Permata Sari Hospital for Plastic Surgery

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Specified Sedative, Hypnotic
    Keywords
    Diphenhydramine, emergence agitation, pediatric anesthesia, PAEDS, Withdrawal

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    diphenhydramine
    Arm Type
    Experimental
    Arm 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
    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Diphenhydramine
    Intervention Description
    Intravenous Injection
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    NaCl 0,9%
    Intervention Description
    Intravenous Injection
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Intervention Description
    Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
    Primary Outcome Measure Information:
    Title
    Incidence of sevoflurane induced post anesthesia agitation
    Time Frame
    10 minutes post extubation
    Secondary Outcome Measure Information:
    Title
    Amount of rescue Ketamine used
    Description
    Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated
    Time Frame
    1 minute post extubation, at emergence, 15 minute post extubation
    Title
    Significant adverse events
    Description
    Any respiratory or cardiovascular events during observation in recovery room
    Time Frame
    1 minute post extubation, at emergence, 15 minute post extubation
    Title
    Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    Time Frame
    1 minute post extubation
    Title
    Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    Time Frame
    at emergence
    Title
    Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
    Time Frame
    15 minute post extubation
    Title
    Incidence of sevoflurane induced post anesthesia agitation
    Time Frame
    1 minute post extubation
    Title
    Incidence of sevoflurane induced post anesthesia agitation
    Time Frame
    15 minute post extubation
    Title
    Length of stay in recovery room
    Time Frame
    up to 15 minutes post extubation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johan Mr Arifin, dr
    Organizational Affiliation
    Universitas Diponegoro
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24257392
    Citation
    Varughese AM, Rampersad SE, Whitney GM, Flick RP, Anton B, Heitmiller ES. Quality and safety in pediatric anesthesia. Anesth Analg. 2013 Dec;117(6):1408-18. doi: 10.1213/ANE.0b013e318294fb4a.
    Results Reference
    background
    PubMed Identifier
    11973185
    Citation
    Cohen IT, Finkel JC, Hannallah RS, Hummer KA, Patel KM. The effect of fentanyl on the emergence characteristics after desflurane or sevoflurane anesthesia in children. Anesth Analg. 2002 May;94(5):1178-81, table of contents. doi: 10.1097/00000539-200205000-00023.
    Results Reference
    background
    PubMed Identifier
    21822077
    Citation
    Koner O, Ture H, Mercan A, Menda F, Sozubir S. Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011 Sep;28(9):640-5. doi: 10.1097/EJA.0b013e328344db1a.
    Results Reference
    background
    PubMed Identifier
    22435268
    Citation
    Abdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16534301
    Citation
    Aouad MT, Nasr VG. Emergence agitation in children: an update. Curr Opin Anaesthesiol. 2005 Dec;18(6):614-9. doi: 10.1097/01.aco.0000188420.84763.35.
    Results Reference
    background
    PubMed Identifier
    12113216
    Citation
    Simons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. No abstract available.
    Results Reference
    background

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

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