Comparison of propofol/fentanyl versus ketamine/midazolam for brief orthopedic procedural sedation in a pediatric emergency department

Pediatrics. 2003 Jul;112(1 Pt 1):116-23. doi: 10.1542/peds.112.1.116.


Purpose: To compare the effectiveness of 2 medication regimens, propofol/fentanyl (P/F) and ketamine/midazolam (K/M), for brief orthopedic emergency department procedural sedation. This study was powered to compare recovery times (RT) and procedural distress as measured by the Observational Score of Behavioral Distress-revised (OSBD-r; range: 0-23.5 with 23.5 representing maximal distress).

Methods: We conducted a prospective, partially-blinded controlled comparative trial comparing intravenous P/F with K/M in a convenience sample of 113 patients aged 3 to 18 years old undergoing orthopedic procedural sedation. All medications were administered by the intermittent intravenous bolus method. An independent sedation nurse recorded total sedation time and RT. Effectiveness was measured using 6 parameters: 1) patient distress as assessed by independent blinded observers after videotape review using the OSBD-r; 2) orthopedic satisfaction score (Likert scale 1-5); 3) sedation nurse satisfaction score (Likert 1-5); 4) parental perception of procedural pain using a 0 to 100 mm Visual Analog Scale with the upper limit being "most pain"; 5) patient recall of the procedure; and 6) 1 to 3 week follow-up.

Results: RT and total sedation time were significantly less in the P/F group than in the K/M group (33.4 minutes vs 23.2 minutes). The mean OSBD-r scores during manipulation were 0.084 and 0.278 for the K/M and P/F groups, respectively. Although this difference was statistically significant (95% confidence interval for the mean difference -0.34 to -0.048), both regimens were successful in keeping the scores low. There was no statistical difference between the groups in the other measures of effectiveness. There was a statistically significant difference between the groups in the occurrence of desaturation and late side effects.

Conclusions: RT with P/F is shorter than with K/M. P/F is comparable to K/M in reducing procedural distress associated with painful orthopedic procedures in the pediatric emergency department. Although propofol has a greater potential of respiratory depression and airway obstruction as compared with ketamine, it offers some unique advantages including a quicker offset and smoother recovery profile.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Analgesics, Opioid / administration & dosage*
  • Analgesics, Opioid / adverse effects
  • Child
  • Child, Preschool
  • Drug Combinations
  • Emergencies*
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Fentanyl / administration & dosage*
  • Fentanyl / adverse effects
  • Hospitals, Pediatric / statistics & numerical data
  • Humans
  • Hypnotics and Sedatives / administration & dosage*
  • Hypnotics and Sedatives / adverse effects
  • Injections, Intravenous
  • Ketamine / administration & dosage*
  • Ketamine / adverse effects
  • Male
  • Midazolam / administration & dosage*
  • Midazolam / adverse effects
  • Orthopedic Procedures*
  • Propofol / administration & dosage*
  • Propofol / adverse effects
  • Prospective Studies
  • Respiration Disorders / chemically induced
  • Single-Blind Method
  • Videotape Recording
  • Wounds and Injuries / therapy


  • Analgesics, Opioid
  • Drug Combinations
  • Hypnotics and Sedatives
  • Ketamine
  • Midazolam
  • Fentanyl
  • Propofol