Cohort
Kathlene E. Bassett, MDPropofol for procedural sedation in children in the emergency department
Annals of Emergency Medicine
December 2003; Volume 42, Number 6, Pages 773-782
- Submitted by:Bradley Laitinen - Emergency Medicine Resident
- Institution:Grand Rapids Medical Education & Research/Michigan State University
- Date submitted:31st March 2007
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, to determine the safety and efficacy of propofol sedation for painful procedures in the emergency department.
2
Design
2.1
Is the study design suitable for the objectives?
Yes, they performed a consecutive case series of propofol sedations for painful procedures in the ED.
2.2
Who / what was studied?
Consecutive pediatric patients in the ED of a tertiary care pediatric hospital with injuries requiring painful procedures. The efficacy and safety of propofol for procedural sedation was evaluated in this study.
2.3
Was a control group used if appropriate?
None.
2.4
Were outcomes defined at the start of the study?
Yes, outcomes were defined. Variables measured included incidence of adverse effects of sedation including abnormal vital signs (primarily blood pressure, pulse, and oxygen saturation), episodes of poor perfusion, respiratory depression, partial airway obstruction, or emesis. Any necessary interventions for adverse events were also documented and measured. They also were measuring efficacy, defined as successful completion of the procedure without patient distress and lack of procedure interruption caused by airway or hemodynamic complication. Failure to reduce a fracture because of technical difficulty with reduction, requiring operative reduction, was not deemed a sedation failure. Duration of procedure, duration of sedation, recovery time, and total time in the ED were other variables measured.
2.5
Was this the right sample to answer the objectives?
Yes, Three hundred ninety-three discrete sedation events with propofol were analyzed.
2.6
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
Yes, but sample size estimates not clearing stated in study.
2.7
Were all subjects accounted for?
Yes.
2.8
Were all appropriate outcomes considered?
Yes. All appropriate adverse outcomes were measured. Also, the efficacy of propofol for pediatric procedures and the duration of sedation and ED stay were appropriately measured.
2.9
Has ethical approval been obtained if appropriate?
Yes.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes, as stated above, the variables measured included incidence of adverse effects of sedation including abnormal vital signs (primarily blood pressure, pulse, and oxygen saturation), episodes of poor perfusion, respiratory depression, partial airway obstruction, or emesis. Any necessary interventions for adverse events were also documented and measured. They also were measuring efficacy, defined as successful completion of the procedure without patient distress and lack of procedure interruption caused by airway or hemodynamic complication. Failure to reduce a fracture because of technical difficulty with reduction, requiring operative reduction, was not deemed a sedation failure. Duration of procedure, duration of sedation, recovery time, and total time in the ED were other variables measured.
3.2
Was the assessment of outcomes blinded?
No.
3.3
Was follow up sufficiently long and complete?
Yes, follow up until ED discharge, which occurred after recovery from sedation.
3.4
Are the measurements valid?
Yes, adverse events were documented, as were the sedation
duration, recovery time from sedation, and total time in the ED
duration, recovery time from sedation, and total time in the ED
3.5
Are the measurements reliable?
Yes.
3.6
Are the measurements reproducible?
Yes.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes, clearly described in Table 3, Figure 1, Figure 2, and Figure 3.
4.2
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes.
4.3
How large are the effects within a specified time?
Hypoxia was found in 5%, partial airway obstruction requiring
airway repositioning in 3%, and apnea with assisted ventilation
in 0.8%. All adverse effects were promptly identified and readily
managed without further complication.
airway repositioning in 3%, and apnea with assisted ventilation
in 0.8%. All adverse effects were promptly identified and readily
managed without further complication.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes.
5
Analysis
5.1
Are the data suitable for analysis?
Yes.
5.2
Are the methods appropriate to the data?
Yes.
5.3
Are any statistics correctly performed and interpreted?
Yes, measurements were reported by using descriptive
statistics.
statistics.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes, results correlate with previous studies of use of propofol in the ED in adults.
6.2
Is the discussion biased?
No.
7
Interpretation
7.1
Are the author's conclusions justified by the data?
Yes.
7.2
What level of evidence has this paper presented? (using CEBM levels)
2b.
7.3
Does this paper help me to answer my problem?
Yes, based on this study, propofol appears to be efficacious and safe in pediatric patients in the ED.
8
Implementation
8.1
Can any necessary change be implemented in practice?
Consider use of propofol in pediatric patients requiring sedation.
8.2
What aids to implementation exist?
Propofol, monitoring equipment, and staff already available in the ED.
8.3
What barriers to implementation exist?
Hospital approval of use of propofol in pediatric ED patients.
8.4
Are the study patients similar to your own?
Yes, ED pediatric patients.
8.5
Does the paper give any conclusions that will affect what you will offer or tell your patient?
Yes. Propofol appears to be safe and efficacious in pediatric patients.