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Comparison of N2O Inhalation and Ketamine in Pediatric PSA (PSA)

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ClinicalTrials.gov Identifier: NCT00834730
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : September 15, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
  • 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 or disease Intervention/treatment Phase
Moderate Sedation Laceration Drug: N2O gas vs ketamine Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The recovery time (from completion of laceration repair to recovery of mental state) [ Time Frame: before discharge ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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