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NCT Number: NCT02463929

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

diphenhydramine

Drug

Intravenous Injection

normal saline

Drug

Intravenous Injection

Other names: NaCl 0,9%

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.

Primary outcomes

  1. Incidence of sevoflurane induced post anesthesia agitation

    Time frame: 10 minutes post extubation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Collaborators

  • Permata Sari Hospital for Plastic Surgery

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2015
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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