Comparison of N2O Inhalation and Ketamine in Pediatric PSA

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Moderate Sedation; Laceration

Treatments: Drug: N2O gas vs ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00834730

N2O

Details and patient eligibility

About

• 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

Full 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

Enrollment: 32 patients

Sex: All

Ages: 36 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients with lacerated wound

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Ketamine

Active Comparator group

Description:

Ketamine 2mg/kg IV

Treatment:

Drug: N2O gas vs ketamine

N2O gas

Experimental group

Description:

50%-70% N2O gas inhalation

Treatment:

Drug: N2O gas vs ketamine