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Trial record 83 of 448 for:    diphenhydramine

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

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.

Condition or disease Intervention/treatment Phase
Specified Sedative Hypnotic Drug: Diphenhydramine Drug: normal saline Drug: Ketamine Drug: Sevoflurane Drug: Bupivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
Study Start Date : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

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Arm Intervention/treatment
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
Drug: Diphenhydramine
Intravenous Injection

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.

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
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.




Primary Outcome Measures :
  1. Incidence of sevoflurane induced post anesthesia agitation [ Time Frame: 10 minutes post extubation ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) [ Time Frame: 1 minute post extubation ]
  4. Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) [ Time Frame: at emergence ]
  5. Mean Pediatric Emergence Agitation and Delirium Score (PAEDS) [ Time Frame: 15 minute post extubation ]
  6. Incidence of sevoflurane induced post anesthesia agitation [ Time Frame: 1 minute post extubation ]
  7. Incidence of sevoflurane induced post anesthesia agitation [ Time Frame: 15 minute post extubation ]
  8. Length of stay in recovery room [ Time Frame: up to 15 minutes post extubation ]


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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463929


Sponsors and Collaborators
Universitas Diponegoro
Permata Sari Hospital for Plastic Surgery
Investigators
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Study Director: Johan Mr Arifin, dr Universitas Diponegoro

Publications:
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Responsible Party: Ika Cahyo Purnomo, Doctor, Universitas Diponegoro
ClinicalTrials.gov Identifier: NCT02463929     History of Changes
Other Study ID Numbers: UDiponegoro
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015

Keywords provided by Ika Cahyo Purnomo, Universitas Diponegoro:
Diphenhydramine
emergence agitation
pediatric anesthesia
PAEDS
Withdrawal

Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Anesthetics
Bupivacaine
Ketamine
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Hypnotics and Sedatives