Subdissociative-dose ketamine versus fentanyl for analgesia during propofol procedural sedation: a randomized clinical trial

Abstract

Objectives: The authors sought to compare the safety and efficacy of subdissociative-dose ketamine versus fentanyl as adjunct analgesics for emergency department (ED) procedural sedation and analgesia (PSA) with propofol.

Methods: This double-blind, randomized trial enrolled American Society of Anesthesiology (ASA) Class I or II ED patients, aged 14-65 years, requiring PSA for orthopedic reduction or abscess drainage. Subjects received 0.3 mg/kg ketamine or 1.5 mug/kg fentanyl intravenously (IV), followed by IV propofol titrated to deep sedation. Supplemental oxygen was not routinely administered. The primary outcomes were the frequency and severity of cardiorespiratory events and interventions, rated using a composite intrasedation event rating scale. Secondary outcomes included the frequency of specific scale component events, propofol doses required to achieve and maintain sedation, times to sedation and recovery, and physician and patient satisfaction.

Results: Sixty-three patients were enrolled. Of patients who received fentanyl, 26/31 (83.9%) had an intrasedation event versus 15/32 (46.9%) of those who received ketamine. Events prospectively rated as moderate or severe were seen in 16/31 (51.6%) of fentanyl subjects versus 7/32 (21.9%) of ketamine subjects. Patients receiving fentanyl had 5.1 (95% confidence interval [CI] = 1.9 to 13.6; p < 0.001) times the odds of having a more serious intrasedation event rating than patients receiving ketamine. There were no significant differences in secondary outcomes, apart from higher propofol doses in the ketamine arm.

Conclusions: Subdissociative-dose ketamine is safer than fentanyl for ED PSA with propofol and appears to have similar efficacy.

Trial registration: ClinicalTrials.gov NCT00137085.