Comparison of N2O Inhalation and Ketamine in Pediatric PSA

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00834730
First received: February 1, 2009
Last updated: September 13, 2011
Last verified: September 2011
  Purpose
  • 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

Condition Intervention Phase
Moderate Sedation
Laceration
Drug: N2O gas vs ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The recovery time (from completion of laceration repair to recovery of mental state) [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sedation scale [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
  • pain scale [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]
  • Side effects [ Time Frame: during procedure and bedore discharge and 1day after discharge ] [ Designated as safety issue: Yes ]
  • Satisfaction of parents and clinicians [ Time Frame: before discharge ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ketamine
Ketamine 2mg/kg IV
Drug: N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas
Experimental: N2O gas
50%-70% N2O gas inhalation
Drug: N2O gas vs ketamine
Ketamine : 2mg/kg IV N2O : 50%-70% N2O gas

Detailed Description:
  • 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
  Eligibility

Ages Eligible for Study:   36 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pediatric patients with lacerated wound

Exclusion Criteria:

  • Contraindication of ketamine or N2O gas
  • A wound around eye and mouth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834730

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jin Hee Lee, Professor Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00834730     History of Changes
Other Study ID Numbers: N2O
Study First Received: February 1, 2009
Last Updated: September 13, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014