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

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ClinicalTrials.gov Identifier: NCT02463929
Recruitment Status : Completed
First Posted : June 4, 2015
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
Permata Sari Hospital for Plastic Surgery
Information provided by (Responsible Party):
Ika Cahyo Purnomo, Universitas Diponegoro

Tracking Information
First Submitted Date  ICMJE May 18, 2015
First Posted Date  ICMJE June 4, 2015
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
Incidence of sevoflurane induced post anesthesia agitation [ Time Frame: 10 minutes post extubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
  • Amount of rescue Ketamine used [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 1 minute post extubation ]
  • Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) [ Time Frame: at emergence ]
  • Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) [ Time Frame: 15 minute post extubation ]
  • Incidence of sevoflurane induced post anesthesia agitation [ Time Frame: 1 minute post extubation ]
  • Incidence of sevoflurane induced post anesthesia agitation [ Time Frame: 15 minute post extubation ]
  • Length of stay in recovery room [ Time Frame: up to 15 minutes post extubation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Official Title  ICMJE Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Specified Sedative
  • Hypnotic
Intervention  ICMJE
  • Drug: Diphenhydramine
    Intravenous Injection
  • Drug: normal saline
    Intravenous Injection
    Other Name: 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Diphenhydramine
    • Drug: Ketamine
    • Drug: Sevoflurane
    • Drug: Bupivacaine
  • 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
    Interventions:
    • Drug: normal saline
    • Drug: Ketamine
    • Drug: Sevoflurane
    • Drug: Bupivacaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2015)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02463929
Other Study ID Numbers  ICMJE UDiponegoro
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ika Cahyo Purnomo, Universitas Diponegoro
Study Sponsor  ICMJE Universitas Diponegoro
Collaborators  ICMJE Permata Sari Hospital for Plastic Surgery
Investigators  ICMJE
Study Director: Johan Mr Arifin, dr Universitas Diponegoro
PRS Account Universitas Diponegoro
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP