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NCT Number: NCT00834730

Comparison of N2O Inhalation and Ketamine in Pediatric PSA

* Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients * However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies * We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients

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Key information

Conditions

Moderate Sedation Laceration Lacerations Wounds and Injuries

Age range

36 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

About this study

  • There were 32 children who were randomly assigned
  • Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range [IQR], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p < 0.05)
  • Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
  • No difference was observed in the satisfaction scores by physicians, parents, or nurses.
  • N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily deep sedation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients with lacerated wound

Exclusion criteria

  • Contraindication of ketamine or N2O gas
  • A wound around eye and mouth

Treatment and study plan

N2O gas vs ketamine

Drug

Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas

Primary outcomes

  1. The recovery time (from completion of laceration repair to recovery of mental state)

    Time frame: before discharge

Secondary outcomes

  1. Sedation scale

    Time frame: before discharge

  2. pain scale

    Time frame: before discharge

  3. Side effects

    Time frame: during procedure and bedore discharge and 1day after discharge

  4. Satisfaction of parents and clinicians

    Time frame: before discharge

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.

Acronym: PSA

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 3, 2009
Registry last updated
Sep 15, 2011

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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