a randomized controlled trial of ketamine/propofol versus propofol alone for emergency department...

PAIN MANAGEMENT AND SEDATION/ORIGINAL RESEARCH

A Randomized Controlled Trial of Ketamine/Propofol VersusPropofol Alone for Emergency Department Procedural Sedation

Henry David, MD, Joseph Shipp, PAC

From the Department of Emergency Medicine, University of Missouri–Columbia, Columbia, MO.

Study objective: We compare the frequency of respiratory depression during emergency department proceduralsedation with ketamine plus propofol versus propofol alone. Secondary outcomes are provider satisfaction,sedation quality, and total propofol dose.

Methods: In this randomized, double-blind, placebo-controlled trial, healthy children and adults undergoingprocedural sedation were pretreated with intravenous fentanyl and then randomized to receive either intravenousketamine 0.5 mg/kg or placebo. In both groups, this procedure was immediately followed by intravenouspropofol 1 mg/kg, with repeated doses of 0.5 mg/kg as needed to achieve and maintain sedation. Respiratorydepression was defined according to any of 5 predefined markers. Provider satisfaction was scored on a 5-pointscale, sedation quality with the Colorado Behavioral Numerical Pain Scale, and propofol dose according to thetotal number of milligrams of propofol administered.

Results: The incidence of respiratory depression was similar between the ketamine/propofol (21/97; 22%) andpropofol-alone (27/96; 28%) groups, difference 6% (95% confidence interval �6% to 18%). Withketamine/propofol compared with propofol alone, treating physicians and nurses were more satisfied, lesspropofol was administered, and there was a trend toward better sedation quality.

Conclusion: Compared with procedural sedation with propofol alone, the combination of ketamine and propofoldid not reduce the incidence of respiratory depression but resulted in greater provider satisfaction, less propofoladministration, and perhaps better sedation quality. [Ann Emerg Med. 2011;57:435-441.]

Please see page 436 for the Editor’s Capsule Summary of this article.

Provide feedback on this article at the journal’s Web site, www.annemergmed.com.A podcast for this article is available at www.annemergmed.com.

0196-0644/$-see front matterCopyright © 2010 by the American College of Emergency Physicians.doi:10.1016/j.annemergmed.2010.11.025

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INTRODUCTIONBackground and Importance

Drugs administered for emergency department (ED) proceduralsedation and analgesia include propofol, ketamine,benzodiazepines, opioids, and barbiturates,1-4 with propofol beingparticularly popular despite its potential for respiratory depressionand hypotension.5 Preliminary research suggests that addingketamine to propofol might enhance hemodynamic stability,6-8

decrease respiratory depression,9 and stabilize respiratory drive.10,11

Three observational series of ED ketamine/propofol proceduralsedation suggest that the combination is safe and effective.12-14

ImportanceIf the combination of ketamine/propofol is safer or

more effective than propofol alone, then it would be
preferred. p
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oals of This InvestigationWe wished to compare the incidence of respiratory depression

etween ketamine/propofol and propofol alone for ED proceduraledation. Our secondary objectives were to compare provideratisfaction, sedation quality, and total propofol dose.

ATERIALS AND METHODStudy Design and Setting

We conducted a randomized, double-blind, placebo-ontrolled trial of children and adults receiving proceduraledation from April 2007 until July 2009 in the ED of a 274-ed university teaching hospital with an annual census of greaterhan 40,000 patient visits. The study was approved by theniversity of Missouri institutional review board, and informed

onsent was obtained from all participants or their parents.

election of ParticipantsED attending physicians participating in the study enrolled

atients selected for procedural sedation and analgesia 24 hours

Annals of Emergency Medicine 435

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Ketamine/Propofol Versus Propofol for Procedural Sedation David & Shipp

per day while they were on duty. We excluded patients who werepregnant or who were younger than 1 year and those with a historyof an adverse reaction to anesthesia, underlying cardiac orpulmonary disease, hepatic dysfunction, porphyria, psychiatricillness, allergy to eggs or soybeans, increased intracranial orintraocular pressure, abnormal airway pathology, or an AmericanSociety of Anesthesiologists physical status of III or greater.

Monitoring consisted of cardiac rhythm, blood pressure,respiratory rate, pulse oximetry, and end-tidal CO2 (ETCO2).An ED attending physician and nurse were dedicated tosedation oversight and monitoring. All patients receivedsupplemental oxygen (2 L/minute) according todepartmental protocol. Physicians provided any supportive/resuscitative measures at their discretion and not based onany prespecified criteria.

InterventionsOn receipt of an ED enrollment sheet containing the subject’s

weight, the pharmacy then consulted the next sequential choice inthe prepared randomization sequence (blocks of 10) and prepared a3-mL study syringe containing either ketamine 0.5 mg/kg or anidentical volume of clear placebo solution. The subject, physician,and nurse were thus blinded to group allocation.

Five minutes before sedation, all patients received a singleintravenous dose of fentanyl, either 0.5 or 1.0 �g/kg at the

Editor’s Capsule Summary

What is already known on this topicIt has become popular to combine ketamine andpropofol for emergency department (ED)procedural sedation; however, it remains unclearwhether this method is superior to the use of eitheragent alone.

What question this study addressedDoes the ketamine/propofol combination reducethe risk of respiratory depression compared withpropofol alone?

What this study adds to our knowledgeIn this randomized controlled trial of 193 emergencydepartment patients (half adults, half children), theincidence of respiratory depression was similar betweenketamine/propofol and propofol alone. Providersatisfaction was greater with ketamine/propofol butmay have been influenced by incomplete blinding.

How this is relevant to clinical practiceThe safety parameter of respiratory depressionoccurs at similar frequency with ketamine/propofoland propofol alone.

choice of the treating physician. They then had reflective (

436 Annals of Emergency Medicine

unglasses placed to obscure eye movements from the staff. Thetudy syringe was then administered intravenous during 1inute and then quickly followed by a loading dose of propofolmg/kg during 2 minutes. Repeated boluses of propofol 0.5g/kg were administered as needed to attain or maintain

edation. Patients were thought to be adequately sedated oncehey received a Colorado Behavioral Numerical Pain Scale scoref 0 or 1 (Table 1),15 with attempts to maintain a score of 0 ors close to 0 as patient safety allowed.

ethods of MeasurementThe sedation nurse completed a standardized hospital record,

hich included drugs administered, serial vital signs,onitoring data, and serial Colorado Behavioral Numericalain Scale scores. After the completion of the sedation, thehysician and nurse together completed a second study formetailing the study outcome measures and the occurrence of anyther adverse events.

utcome MeasuresThe primary study outcome was respiratory depression, defined

s occurrence during sedation of any one of the following:ETCO2 increase of greater than 5 mm Hg of 10 or moreseconds in durationRespiratory rate less than 8 breaths/min of 10 or moreseconds in durationSaO2 less than 90% of 10 or more seconds in durationApnea greater than 15 seconds (defined as no visiblerespiratory effort)Airway manipulation (defined as the need for jawrepositioning or use of a bag-valve-mask device)For secondary outcomes, the physician and nurse

ndependently recorded their satisfaction with the overall qualityf the sedation on a 5-point scale as follows: 1�not satisfied,�somewhat satisfied, 3�satisfied, 4�very satisfied, and�excellent. For analysis, we dichotomized satisfaction scores ofto 3 versus 4 or 5. Quality of sedation was quantified by theroportion of subjects maintaining a Colorado Behavioralumerical Pain Scale score of 0 or 1 throughout their sedation

ncounter. Total propofol dose was measured as the cumulativeuantity administered.

We compared categorical outcomes with �2 or the Fisherxact test (Primer of Biostatistics 6.0, Stanton A. Glantz, 2005).

e calculated confidence intervals (CIs) with CIA software

able 1. Colorado Behavioral Numerical Pain Scale.

core Behavior

0 Restful, no facial expression1 Moaning, frowning, restless2 Facial grimacing, protective body positioning3 Resistive, crying out4 Yelling, tossing about5 Combative

version 2.1.2; Trevor N. Bryant, 2000).

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David & Shipp Ketamine/Propofol Versus Propofol for Procedural Sedation

We calculated our sample size to detect a 20% differencein a 40% baseline incidence of respiratory depression withpropofol alone, assuming an � of .05 and a power of 0.8.16-

18 This specified 100 patients in each group. An interimanalysis performed halfway through showed no significantdifference at P�.025 and so the trial was completed.

RESULTSPatient flow is shown in Figure 1. Baseline characteristics

were similar between groups, except more men were in thepropofol-alone group (Table 2). Young children were unableto tolerate the sunglasses 2 times in the ketamine/propofolgroup and 4 times in the propofol-alone group.

For our primary outcome, the incidence of respiratorydepression was similar between groups (Table 3; P�.38),including comparisons of the individual markers (Table 4). Inthe ketamine/propofol group, 2 subjects received bag-valve-mask ventilation and 8 a jaw thrust compared with 5 and 9,respectively, in the propofol-only group.

For our secondary outcomes, provider satisfaction wassignificantly higher in the ketamine/propofol group forphysicians and nurses (Table 3; Figures 2 and 3; P�.001).

Figure 1. Flow chart of patients

This group also received significantly less propofol (Table 3). (

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he proportion of subjects with sedation scores of 0 or 1 wastatistically similar between groups (Table 3) but exhibited aisible trend favoring the ketamine/propofol group

able 2. Baseline characteristics of ketamine/propofol andropofol-alone groups.

roup CharacteristicsKetamine/Propofol

(n�97)Propofol Alone

(n�96)

ge, y, median (range) 20 (2–83) 22 (2–75)ge �18 y (%) 48 (50) 45 (47)ale (%) 52 (54) 62 (65)eight, kg, median (range) 60 (12–120) 70 (10–130)SA class I (%) 88 (91) 90 (94)SA class II (%) 9 (9) 6 (6)entanyl dose (0.5 �g/kg) (%) 74 (76) 69 (72)entanyl dose (1.0 �g/kg) (%) 23 (24) 27 (28)rocedure length, min, median (range) 15 (6–33) 15 (6–39)rocedure (%)Fracture/dislocation 84 (87) 85 (89)Suturing 9 (9) 5 (5)Foreign body removal 1 (1) 3 (3)Abscess I&D 2 (2) 3 (3)Chest tube insertion 1 (1) 0

SA, American Society of Anesthesiologists; I&D, incision and drainage.

ded in the statistical analysis.

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In post hoc analyses, ketamine/propofol subjects spent 2%more of their pooled total sedation time at either a score of 0 or1 relative to propofol alone (99% versus 97%), and 9% more oftheir sedation time at a score of 0 (93% versus 84%). In theketamine/propofol group, there were a total of 31 individualepisodes in 29 subjects of sedation becoming lighter by a scorepoint, whereas in the propofol-alone group, there were 64 suchchanges observed in 45 subjects. Satisfaction scores were poorlycorrelated to sedation scores (Spearman’s � –0.13 for physiciansand –0.16 for nurses).

There were no episodes of hypersalivation, emergencereactions, or other serious adverse events in either group.

LIMITATIONSThe principal limitation to our study was the challenge of

Table 3. Outcome variables: respiratory depression, provider sapropofol dose per patient.

Outcome Variables Ketamine/Propofo

Respiratory depression 21/97 (22)Physician satisfaction (% with score of 4 or 5) 92/97 (95)Nurse satisfaction (% with score of 4 or 5) 91/97 (94)Quality of PSA (CBNPS�0 or 1 throughout) 91/97 (94)Total propofol dose, mg, median (range) 100 (14 to

CBNPS, Colorado Behavioral Numerical Pain Scale.

Table 4. Individual episodes of airway depression markeroccurrence.*

Markers ofRespiratoryDepression

Ketamine/Propofol,No. (%)(n�97)

PropofolAlone, No.(%) (n�96)

Difference, %(95% CI)

ETCO2 �5 mm Hg 11 (11) 20 (21) 10 (�1 to 20)Respiratory rate �8

breaths/min3 (3) 5 (5) 2 (�4 to 8)

SaO2 �90% 7 (7) 11 (12) 5 (�4 to 13)Apnea �15 s 2 (2) 4 (4) 2 (�3 to 7)Airway manipulation 10 (10) 14 (15) 5 (�5 to 14)

*Several patients experienced more than a single marker of respiratory depres-sion.

Figure 2. Physician provider satisfaction scores (1 to 5).

maintaining blinding with ketamine. Although we used t


unglasses to obscure nystagmus, 3% of subjects could notolerate them and were thus likely unblinded. We did not findhat the glasses impaired monitoring, as has been describedlsewhere.19 We observed that some subjects became quiet aftereceiving the study intervention, potentially unblinding them.

e did not count how often this occurred, nor did we haveroviders attempt to guess group assignments to quantify ourlinding efficacy. Most of our study outcomes are objective andhus should remain reliable, regardless; however, provideratisfaction scoring is subjective and may have been influencedy observer bias.

A second limitation is that the Colorado Behavioralumerical Pain Scale has been validated only in adults.owever, because our targeted sedation depth was deep

edation we believe that it should likely reflect sedation qualityn children as well.

ISCUSSIONTo our knowledge, we report the first randomized controlled

rial of ketamine/propofol versus propofol alone in the EDetting. Although both regimens demonstrate similar evidencef safety according to our primary outcome of respiratoryepression, we observed differences in our secondary outcomesavoring the ketamine/propofol group.

First, we observed that sedation could be maintained withignificantly less propofol in the ketamine/propofol group. Thisnding may lack clinical importance because the additionalropofol wears off quickly and does not significantly increase

ction, quality of procedural sedation and analgesia, and total

(n�97) Propofol Alone, % (n�96) Difference, % (95% CI)

27/96 (28) 6 (�6 to 18)62/96 (65) 30 (20 to 40)70/96 (73) 21 (11 to 31)86/96 (90) 4 (�4 to 12)

) 175 (20 to 730) 75 (37 to 111)

Figure 3. Nurse provider satisfaction scores (1 to 5).

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he frequency of respiratory depression. However, given that

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propofol is a potent respiratory depressant, any sedationregimen that can maintain efficacy and safety with a lesser drugrequirement has at least theoretic value.

We observed a trend favoring more effective sedation in theketamine/propofol group (Figure 4). Our exploratory analysissuggests that the cause of this difference is less frequent changesin sedation depth. Thus, although both regimens can achieveeffective deep sedation, that resulting from the combinationappears more consistent. Subsequent trials, possibly using morestrict sedation level criteria, are needed to further investigate andconfirm this finding.

Our most striking secondary outcome was the markedlygreater provider satisfaction with ketamine/propofol. This didnot correlate with sedation scores and thus reflects features ofsedation that transcend simple sedation depth. Possibilitiesinclude the more consistent sedation already described or thedecreased need to titrate additional propofol. Alternatively,challenges to blinding may have exaggerated this subjectiveoutcome.

Previous ED observational series have suggested that the

Figure 4. Percentage of the procedure spent at eachsedation level.

addition of a subdissociative dose of ketamine to propofol is safe S

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nd may have a role in ED procedural sedation.12-13,19 Bothetamine and propofol have been studied extensivelyndividually or in conjunction with other sedatives/analgesics.etamine has demonstrated a wide margin of safety, with very

ittle risk of serious adverse effects.20-22 Propofol demonstrateshe highly desirable characteristics of rapid onset and extremelyhort half-life and, although also very safe for ED sedation, is moreikely than ketamine to induce hypoxia or hypotension.23-26

The opposing hemodynamic and respiratory effects ofetamine and propofol suggest the potential for synergy. Theombination has been used outside the ED for sedation, withositive results.9,27-29 Specifically, Frey et al27 and Akin et al9

ound that there may be reduced rates of respiratory depressionnd increased quality of sedation when a combination ofetamine/propofol was compared against propofol alone andentanyl/propofol, respectively. Hwang et al28 observed aeduced systolic blood pressure during fiberoptic bronchoscopyn patients undergoing sedation with ketamine/alfentanilompared with those receiving a ketamine/propofolombination. In his review of the literature concerningetamine/propofol combination, Arora30 observed thatlthough there are only a few small studies published, theyuggest that the combination of ketamine/propofol may be safernd more efficacious.

We chose to preadminister fentanyl analgesia becauseropofol is not an analgesic and is commonly supplementedith an opioid.31 Unfortunately, opioids potentiate the

espiratory depression of propofol. The alternative use ofetamine, which typically maintains normal respiratoryunction,32 could theoretically decrease the risk of respiratoryepression. Mourad et al33 showed that when low-doseetamine was used in conjunction with propofol for proceduraledation and analgesia, a significant reduction in the amount ofropofol required for sedation was observed. The mechanism ofhis effect is not clear. It has been stated that ketamine in lesshan dissociative doses does not have anesthetic effects butather has analgesic effects.34 It may be that the addition ofetamine to fentanyl/propofol has a synergistic anesthetic effectith propofol, potentiates the sedative activity of propofol, orroduces enough analgesia to allow a lower dose of propofol toroduce the desired sedation level.

We observed no emergence reactions or hypersalivation withetamine despite the lack of pretreatment with annticholinergic, which has been observed with subdissociativeoses of ketamine and in particular when ketamine is combinedith propofol.19,35

In conclusion, the addition of a subdissociative dose ofetamine to propofol did not significantly reduce respiratoryepression. However, it did result in greater provideratisfaction, a decreased propofol requirement, and a trendoward more effective sedation.

upervising editor: Steven M. Green, MD


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Author contributions: HD and JS conceived the study,designed the protocol, obtained departmental funding for thetrial, and supervised the conduct of the trial and its datacollection, including quality control. HD analyzed the data anddrafted the article. Both authors contributed substantially toits revision. HD takes responsibility for the paper as a whole.

Funding and support: By Annals policy, all authors are requiredto disclose any and all commercial, financial, and otherrelationships in any way related to the subject of this articlethat might create any potential conflict of interest. The authorshave stated that no such relationships exist. See theManuscript Submission Agreement in this issue for examplesof specific conflicts covered by this statement.

Publication dates: Received for publication April 7, 2010.Revisions received August 1, 2010; September 24, 2010;and November 15, 2010. Accepted for publication November19, 2010. Available online January 21, 2011.

Reprints not available from the authors.

Address for correspondence: Henry David, MD, University ofMissouri-Columbia, One Hospital Drive, Columbia, MO; 65212;573-882-3496, fax 573-884-5410; [email protected].

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33. Mourad M, Mostafa E, Mohammed A, et al. Low dose ketaminereduces sedative doses of propofol during ambulatory trans-
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197.
IMAGES IN EMERGENCY MEDICINE(continued from p. 434)

DIAGNOSIS:Cutaneous granuloma of sarcoidosis. Due to interference with her daily activities, the patient opted for partial

index finger amputation proximal to the lesion. Surgical pathology confirmed the lesion to be a non-necrotizinggranuloma with negative acid-fast bacillus and fungal stain results, consistent with granulomata of sarcoidosis.


a randomized controlled trial of ketamine/propofol versus propofol alone for emergency department...

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