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Pediatric Anesthesia 2009

19: 748–755

doi:10.1111/j.1460-9592.2009.03054.x

Quality of recovery from two types of general anesthesia for ambulatory dental surgery in children: a double-blind, randomized trial ¨ N IG M D * †, A N N A M . V A R U G H E S E M D MATTHIAS W. KO M P H * †, K A T H L E EN A . BR E N N EN C R N A *, SEAN BA RC LAY C R N A * , T . M I C H A E L S H A C K L E F O R D D O *†, P AUL J. S A M U E L S M D *†, K RI ST IN GO RM AN B S * , J I L L I A N E L LI S B A * , Y U W A N G M S ‡ A N D T O D D G . N I C K P H D †‡ *Department of Anesthesiology, †Department of Pediatrics, University of Cincinnati College of Medicine and ‡Division of Biostatistics and Epidemiology, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA

Summary Background: Pediatric dental procedures are increasingly performed under general anesthesia because of the inability to cooperate, situational anxiety, or other behavioral problems. Volatile anesthetics have been associated with emergence delirium in children, whereas the use of propofol for anesthetic maintenance has been shown to reduce the incidence of emergence delirium after other types of surgeries. The aim of this study is to compare a sevoflurane-based anesthetic with a propofol-based technique as it relates to the incidence of emergence delirium and the quality of recovery after pediatric dental surgery, in patients who present with risk factors for perioperative behavioral issues. Methods: We prospectively collected data of 179 pediatric patients scheduled for ambulatory dental surgery using a double-blind and randomized trial design. Subjects were anesthetized following standardized protocols for either a sevoflurane- or a propofol-based technique. The incidence of emergency delirium, as measured by the Pediatric Anesthesia Emergence Delirium score, was the primary outcome. Secondary outcomes included the incidence of postoperative nausea and vomiting (PONV), number of nursing interventions in the recovery room, time to discharge readiness, and parental satisfaction. Results: We found no difference in the incidence of emergence delirium after both types of anesthesia. However, use of sevoflurane significantly increased both the risk of PONV and the number of postoperative nursing interventions. Discharge criteria were met about 10 min earlier in patients anesthetized with sevoflurane. Parental satisfaction was equally high with both anesthesia regimens.

Correspondence to: Matthias W. Ko¨nig MD, Department of Anesthesiology, Cincinnati Children’s Hospital Medical Center, MLC 2001, 3333 Burnet Avenue, Cincinnati, OH 45229-3039, USA (email: matthias.konig@cchmc.org).

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Conclusions: A propofol-based anesthetic technique did not lead to a lower incidence of emergence delirium after dental surgery in children but did result in significantly less PONV and fewer postoperative nursing interventions. Keywords: dental anesthesia; emergence delirium; propofol; sevoflurane

Introduction In recent years, an increasing number of ambulatory dental procedures are being performed under general anesthesia (GA). These procedures include tooth extractions and dental rehabilitation, such as cavity treatment, teeth cleaning, and crown placement. The American Academy of Pediatric Dentistry has identified a list of indications for the use of GA, including the inability to cooperate because of extreme fearfulness or anxiety, as well as lack of emotional maturity or mental, physical, and medical disability (1). A significant number of patients are referred for dental procedures under GA, because they are unable to have a dental procedure performed in the office under sedation and local anesthesia because of behavioral issues. Thus, this patient population presents with risk factors for perioperative behavioral problems (2–4). Use of volatile anesthetics has been associated with frequent, transient emergence delirium in pediatric patients, which manifests as inconsolable crying, screaming and disorientation, as well as thrashing and kicking. This often leads to more frequent nursing interventions in the PACU and increased length of PACU stay. At times, there is a need for temporary restraints or pharmacologic intervention to prevent adverse events such as increased bleeding from surgical sites, accidental removal of surgical drains or IV lines, increased surgical pain, and minor injuries to nursing staff (5,6). The use of intravenous propofol for maintenance of anesthesia has been shown to reduce the incidence of emergence delirium in other surgical procedures when compared to volatile anesthetics. Further, propofol has been found to lower the incidence of postoperative nausea and vomiting (PONV) when compared to volatile agents (7,8).

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We therefore prepared to study the effects of propofol vs that of the volatile anesthetic sevoflurane for anesthetic maintenance on the quality of recovery in a population that presents with risk factors for postoperative behavioral problems. The incidence of emergence delirium is the primary outcome. Secondary outcomes are the incidence of PONV, number of nursing interventions (physical restraint, administration of rescue medication), time to discharge readiness, and parental satisfaction.

Materials and methods After obtaining parental consent and approval from our Institutional Review Board, we enrolled 184 patients, 2–12 years of age, who were scheduled for ambulatory dental surgery under GA at Cincinnati Children’s Hospital Medical Center and its ambulatory surgery center in Mason, OH (March 2007–April 2008). Children with and without psychiatric, behavioral and ⁄ or developmental history were included. Patients with a medical contraindication to the use of any of the study drugs, a history of malignant hyperthermia, or with ASA physical status III or greater were excluded from participation. Study subjects were randomly assigned by a computer-generated randomization table to receive either a propofol- (group P) or a sevoflurane-based (group S) anesthetic. All subjects received oral premedication with 20 mgÆkg)1 acetaminophen. At the discretion of the anesthesiologist, subjects also received oral midazolam 0.5 mgÆkg)1, if deemed necessary. Trained observers were blinded to the anesthetic techniques and intraoperative drugs. Anesthesia induction was performed using sevoflurane in 66% N2O in O2 by mask in all subjects with parents being present. Patient behavior during the induction process was assessed by trained observers using the Induction Compliance Checklist


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(ICC). The ICC is a score from 0 to 10 measuring the cooperation with an inhalational induction using a checklist of 10 behavioral items (9). A low ICC score identifies a smooth induction; a high score represents a stormy induction. After placement of intravenous access, all patients received fentanyl 2 mcgÆkg)1, dexamethasone 0.5 mgÆkg)1, and propofol 2 mgÆkg)1. The airway was then secured with a preformed nasal endotracheal tube, and ventilation was controlled to achieve normocapnia. In group P, anesthesia was maintained with a continuous infusion of propofol at a starting rate of 250 mcgÆkg)1Æmin)1, and subjects were ventilated with 66% N2O in O2. The infusion rate was reduced every 20 min by 50 mcgÆkg)1Æmin)1 to a minimum of 120 mcgÆkg)1Æmin)1 (10,11). If necessary, additional propofol boluses of 1 mgÆkg)1 could be administered for clinical signs of light anesthesia such as patient movement. In group S, anesthesia was maintained with sevoflurane at an end-tidal concentration of 2% in 66% N2O in O2. If necessary, the sevoflurane concentration could be increased in 0.5% increments for clinical signs of light anesthesia such as patient movement. Subjects in both groups could receive additional boluses of fentanyl 1 mcgÆkg)1 if clinically indicated during the procedure (heart rate and ⁄ or blood pressure increase >20% relative to baseline for >60 s). Spontaneous respirations were allowed to recover during the last 30 min of the procedure. All patients with more than one dental extraction received morphine 0.05 mgÆkg)1. After conclusion of the dental procedure, all patients were extubated in a deep plane of anesthesia and then transferred to the PACU. In the PACU, all patients could receive additional fentanyl for pain (0.5 mcgÆkg)1 for mild pain, 1 mcgÆkg)1 for severe pain) as well as ondansetron 0.1 mgÆkg)1 for nausea or vomiting. Pain assessment was performed by PACU nursing staff using age appropriate scales (FLACC, Oucher, VAS). Emergence behavior in the PACU was graded by trained observers using the recently validated Pediatric Anesthesia Emergence Delirium (PAED) scale (12). The PAED score rates five types of behaviors associated positively or negatively with emergence delirium and results in an aggregate score of 0–20. Higher scores correspond to a higher degree of

emergence delirium. Children were evaluated with the PAED score every 5 min after awakening for 30 min. The highest score during this period for each of the five behaviors was used to compute the final PAED score. Prior to discharge, parents were asked to rate their satisfaction with their child’s recovery experience on a scale from 0 to 10, 0 being the worst possible experience and 10 being the best possible experience.

Sample Size With 92 subjects randomly assigned to each group, the study would have 90% power to detect a probability of 0.638 that the PAED score in one group is less than the PAED score in the other group, using two-sided Wilcoxon–Mann–Whitney (WMW) test with a 0.05 significance level. For sample size calculation, NQUERY ADVISOR 6.0 (Statistical solutions, Saugus, MA, USA) was used.

Statistical analysis Descriptive statistics were computed for patient demographics and medical history, including age, weight, gender, current medications, psychiatric ⁄ behavioral history, developmental history, quality of prior anesthetics and dental experiences. To determine possible imbalances between the two groups, ICC score during the induction, total amount of fentanyl given in the operation room, midazolam premedication, as well as types of dental surgery procedures, and duration of these procedures were compared between groups P and S. All numerical measures were presented as median and interquartile range, and categorical measures were presented as frequencies and proportions. Differences between anesthetic groups on the primary outcome, the PAED score, were determined using WMW test. Hodges–Lehmann estimate and its 95% confidence interval (CI) were used to estimate the magnitude of difference in PAED scores between two groups (13). The relationship between the PAED score and several factors was investigated using Spearman’s rank correlation coefficient, rs, or Kruskal–Wallis rank sum test. The secondary outcomes including the incidence of PONV, number of nursing interventions, time to discharge readiness, and parental satisfaction were

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compared between the two groups using WMW test, Pearson’s Chi-square test, or Fisher’s exact test. Odds ratio and its 95% CI were used to report the effect size for PONV, nursing intervention in PACU, and parental satisfaction. The difference in the time to discharge readiness was given by Hodges– Lehmann estimate and its 95% CI. Additional adjusted analyses were conducted using multivariable regression models to assess the effects of covariates. Multivariable linear regression model for the rank of PAED score and multivariable logistic regression model for PONV were fitted with site, age, gender, psychiatric ⁄ behavior history, negative anesthesia or dental experience, behavior during induction of anesthesia (ICC score), and dental extraction (yes ⁄ no) as covariates (14). All tests were two-sided and used a significance level of 0.05. S-PLUS 8.0 (Insightful Corporation, Seattle, WA, USA) was used for all statistical analyses.

Results Five patients were excluded from the data analysis because of protocol violations, one with an equipment problem and four with airway concerns on the part of the responsible anesthesiologist, leading to the decision not to extubate in a deep plane of anesthesia. Patients randomized into either group S or group P were similar with regard to demographics and medical history. However, there were significant differences between anesthetic groups regarding experiences with dental procedures in the dentist’s office: 15% of subjects in the group S vs 6% in group P reported no office experience, and 30% of subjects in group S vs 45% in group P had a failed dental office procedure or failed sedation in the office (Table 1). No significant differences were noted in the percentages of subjects requiring premedication with midazolam, median ICC scores, the amount of intraoperative fentanyl used, complexity of dental treatment, and duration of procedure (Table 2). For the primary outcome, the PAED score, no significant difference in the median PAED scores was noted between anesthetic groups although subjects in group S had a wider interquartile range than subjects in group P (Table 3). Twenty-nine percent (26 of 91) subjects in group S had PAED scores >10 and only 17% (15 of 88) subjects in group P had PAED scores >10 (Table 4).

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Table 1 Descriptive summary of the study population Sevoflurane (N = 91) Male, n (%) 52 (57) Age, median (25th, 75th 56 (44, 72) percentiles), (month) Weight, median (25th, 18.6 (16.3, 22.4) 75th percentiles), (kg) No Medication, n (%) 61 (67) Psychiatric ⁄ behavioral history, n (%) None 78 (86) Anti-social ⁄ aggressive 0 (0) behavior Attention deficit disorder 1 (1) ADHD 7 (8) Autism 5 (6) Bipolar disorder 1 (1) Oppositional disorder 0 (0) Developmental historya, n (%) Age-appropriate 76 (84) Delayed 14 (15) If delayed, functional age, n (%) Toddler 3 (3) Preschool 3 (3) Early primary school 4 (4) Late primary school 2 (2) Unsure 2 (2) Anesthetic experience, n (%) None 54 (59) Uneventful 32 (35) Uncooperative with 5 (6) induction Severe agitation in PACU 0 (0) Dental office experienceb, n (%) None 14 (15) Uneventful 49 (54) Uneventful after sedation 1 (1) Failed sedation or 27 (30) office procedure

Propofol (N = 88) 51 (58) 53 (38, 79) 18.6 (15.4, 22.0) 67 (76) 81 (92) 1 (1) 1 4 3 1 1

(1) (5) (3) (1) (1)

79 (90) 9 (10) 2 5 0 0 2

(2) (6) (0) (0) (2)

48 (55) 35 (40) 4 (5) 1 (1) 5 42 1 40

(6) (48) (1) (45)

a One patient had no such information. bP = 0.04 using Fisher’s exact test. ADHD, attention deficit hyperactivity disorder.

Table 5 shows the Spearman rank correlation coefficients of PAED score with several factors. A significant but weak correlation (rs = 0.18, P = 0.02) was observed between premedication with midazolam and the PAED score with premedicated subjects having higher scores. Another significant, moderate correlation (rs = 0.39, P < 0.0001) was seen between the requirement for rescue medication for pain and the PAED score. Subjects who needed rescue medication had higher PAED scores. No significant correlation was seen between psychiatric ⁄ behavioral history (P = 0.23), developmental history (P = 0.08) or ICC score (P = 0.40), and the PAED score. A weak correlation (rs = 0.16, P = 0.03) existed between the


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Table 2 Summary of the clinical factors Sevoflurane (N = 91) Induction Compliance Checklist score, median (25th, 75th percentiles) Fentanyl, median (25th, 75th percentiles), (mcg) Midazolam premedication, n (%) Procedure, n (%) Placement of more than one crown More than one extraction Intraoperative morphine administration Lidocaine infiltration Duration of procedure, n (%) 30–60 min 60–90 min 90–120 min >120 min

Propofol (N = 88)

Table 4 Distribution of Pediatric Anesthesia Emergence Delirium (PAED) score P value a

0 (0, 4)

0 (0, 3)

0.47

40 (35, 50)

40 (30, 50)

0.84a

49 (54)

49 (56)

0.92b

52 (57)

50 (57)

b

0.91

45 (49) 45 (49)

34 (39) 34 (39)

0.19b 0.19b

35 (38)

27 (30)

0.35c

8 44 26 13

6 37 30 15

0.88b

(9) (48) (29) (14)

(7) (42) (34) (17)

a Two-sided Wilcoxon–Mann–Whitney test. bTwo-sided Pearson’s Chi-square test with Yate’s correction. cChi-square test with Yate’s correction.

duration of the procedure and the PAED score, the longer the procedure, the higher the PAED score. Two-sided Kruskal–Wallis rank sum test showed a significant difference in PAED score between invasiveness of the procedure (P = 0.01). The PAED scores were higher with the increasing invasiveness from ‘only extraction’ to ‘only crowns’ to ‘crowns

Outcomes Pediatric Anesthesia Emergence Delirium score, median (25th, 75th percentiles) Postoperative nausea and vomiting (PONV), n (%) Nursing intervention, n (%) Physical restraint Rescue medication For PONV For pain For sedation ⁄ chemical restraint Timef, median (25th, 75th percentiles), (min) Parental satisfaction scoreg, n (%) 10 (the best possible experience) <10

PAED score

Sevoflurane N = 91 (%)

0–5 6–10 11–15 >15

39 26 21 5

Midazolam premedication Developmental history Psychiatric ⁄ behavioral history Induction Compliance Checklist score Duration of procedure Rescue medication for pain

Effect size

P-value

6 (3, 11)

7 (4, 9)

0 ()2, 1)a

0.66b

5.3 (1.1, 25.0)c

0.03d

2.9 (1.5, 5.6)c 11.3 (0.6, 206.6)c 2.6 (1.3, 5.1)c

9 (2, 17)a

0.003e 0.06d 0.008e 0.06d 0.20e 0.49d 0.02b

1.1 (0.5, 2.2)c

0.95b

37 5 35 9 26 0 60

(41) (6) (38) (10) (29) (0) (42, 71)

73 (80) 18 (20)

17 0 17 2 17 1 70

(19) (0) (19) (2) (19) (1) (55, 85)

69 (79) 18 (20)

35 38 14 1

(40) (43) (16) (1)

Spearman correlation coefficient (rs)

P value

0.18 )0.13 0.09 0.06 0.16 0.39

0.02 0.08 0.23 0.40 0.03 <0.0001

and extractions’ (Figure 1). However, duration of procedure and invasiveness of procedure were not independent of each other [Spearman correlation = 0.34 (P < 0.0001)]. Multivariable linear regression model for the rank of PAED score did not show significant effect of the anesthetic techniques, either, after adjusting for the covariates including site and gender, etc. However,

Propofol (N = 88)

2 (2)

(43) (29) (23) (5)

Table 5 Correlation of Pediatric Anesthesia Emergence Delirium score with factors

Sevoflurane (N = 91)

10 (11)

Propofol N = 88 (%)

Table 3 Comparison of the outcome measures between anesthetic groups

a

Hodges–Lehmann estimate and 95% Confidence Interval of the difference of location (Propofol– Sevoflurane). bTwo-sided Wilcoxon–Mann–Whitney test. cOdds ratio (Sevoflurane : Propofol) and its 95% Confidence Interval, 0.5 correction is added if zero count appears. dTwo-sided Fisher’s exact test. eTwo-sided Pearson’s Chi-square test with Yate’s correction. fTime to discharge readiness. gOne missing value existed.

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20

PAED score

15

10

5

0 Crown and exraction

Crown only Dental procedure

Exraction only

Figure 1 Pediatric Anesthesia Emergence Delirium score vs dental procedure. Only patients having crown placement or ⁄ and tooth extraction were considered; thus, 140 patients were included in this analysis.

age had a significant effect on the rank of PAED score (regression coefficient = )0.38, P = 0.02) with older children having lower PAED scores. No significant interaction between age and anesthetic technique was noted (P = 0.56). Significant differences between anesthetic groups were observed for some secondary outcomes (Table 3). Incidence of PONV was higher in group S (P = 0.03). Compared to subjects in group P, subjects in group S were significantly more likely to have PONV (odds ratio = 5.3, 95% CI = 1.1–25.0). No additional significant factors besides the anesthetic technique were noted from the multivariable logic regression model for PONV. More subjects in group S needed nursing interventions in PACU than in group P (41% vs 19%, P = 0.003). No subjects required physical restraint in group P, but five subjects in group S required physical restraint. Significantly, more subjects in group S required rescue medication than in group P (38% vs 19%, P = 0.008), and most of those subjects required medication for pain. The median time to discharge readiness was 10 min longer in group P (P = 0.02). No significant difference was observed with regard to the parental satisfaction with the overall experience with the child’s recovery period.

Discussion In contrast to several previous studies, we did not find a significant difference in the incidence of

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emergence delirium between a propofol- and a sevoflurane-based anesthesia technique as measured by the PAED score in children undergoing dental procedures. The significantly lower incidence of PONV in the P group and the corresponding higher demand for postoperative ondansetron in the S group are in agreement with previous studies (15,16). The most surprising finding was the very significantly higher number of all nursing interventions in the S group, especially regarding the need for physical restraint and rescue medication (mostly for pain). The shorter time to meet discharge criteria we observed after sevoflurane anesthesia has been reported by others as summarized by Moore et al. (15). Since the first descriptions of pediatric ‘emergence delirium’ by Eckenhoff et al. (17), all subsequent studies on this subject have been plagued by the problem of defining and quantifying this phenomenon. Most authors have relied on unvalidated, simple scoring systems that made comparisons between papers using different scores difficult, if not impossible (18). Furthermore, the distinction between agitation because of pain and emergence delirium continues to be problematic. The PAED score introduced by Sikich et al. (12) in 2004 presents the first scoring system that allowed a more complex evaluation of emergence delirium based on actual psychiatric definitions of delirium. Further, it has been assessed for reliability and validity. Unfortunately, the PAED score is a continuous score without a defined cutoff to define the presence of emergence delirium. The number of studies using the PAED scale is still limited, and it is difficult to compare their results with other studies using less welldefined scoring systems. Our PAED scores in the P group are very comparable to those found in similar technique comparisons by Mayer and Kol (19,20), but in contrast to them we observed no increase in median PAED scores in the S group. However, we noted a greater interquartile variability of the PAED scores in the S group and a higher proportion of subjects with scores of >10 (17% in P group vs 29% in S group). Similar to Aono et al., we found a significant age effect on the PAED scores with younger children having higher scores (21). Interestingly, subjects in the S group required more rescue medication (mostly for pain), and they also needed to be physically restrained significantly


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more often than subjects in the P group. Need for pain medication in the PACU correlated moderately with the PAED score. Similarly, the level of invasiveness of the procedure (extractions vs crowns vs crowns and extractions) had a significant influence on the PAED. Administration of opioids has been shown to be increased in ‘agitated’ patients and seems to be a common ‘treatment’ for agitated children in the PACU – regardless of the cause (5,22). As Voepel-Lewis pointed out in a recent letter, agitation is a multifactorial behavior and may be caused by pain, delirium, or other factors (23). Because the PAED score was designed to capture the element of delirium, it seems possible that those patients with increased opioid consumption in our study would have been all labeled as having emergence delirium if another scoring system had been used. Thus, our results underscore again the difficulty of differentiating agitation because of pain from true emergence delirium. Furthermore, it might be argued that even the PAED score, as one of the most sophisticated instruments available for the measurement of emergence delirium, may not ultimately capture all facets of this phenomenon. A very recent paper by Cheng et al. suggests another potential explanation for the increased use of postoperative analgesia in the S group; In an adult population, the authors were able to show that a propofol-based anesthetic led to lower analgesic requirements in the immediate postoperative period than a balanced anesthetic with isoflurane (24). Potential explanations for the low levels of emergence delirium in both groups might be the extubation at a deep plane of anesthesia, which – at least anecdotally – may produce a calmer awakening. To our knowledge, there is no published evidence in support of this theory. A further explanation might be the amount of fentanyl given during the procedures. Intraoperative use of narcotics, especially fentanyl, has been shown to have some prophylactic effect on the occurrence of emergence delirium in short procedures such as adenoidectomies (25,26). However, given the duration of the dental procedures in our study and the moderate median dose of 2.15 mcgÆkg)1 fentanyl per patient administered primarily at the beginning of surgery, it appears unlikely that the dose of intraoperative fentanyl could have very pronounced effects on the postoperative phase.

It could be argued that premedication with oral midazolam constitutes a confounding factor in our study regarding emergence delirium, because about half of the subjects in each group (P group 54%, S group 56%) received it preoperatively. However, we felt that in order to be representative of contemporary anesthesia practice the optional use of midazolam premedication should be included in our protocol. In our study population, we found a positive, but weak, correlation between midazolam premedication and the PAED score. The evidence published so far is equivocal as to whether or not midazolam exerts significant effects on emergence delirium (27–29). Our results confirm the previously reported low incidence of PONV after propofol-based anesthesia as reviewed by Moore et al. (15). Given that PONV constitutes a leading cause of postoperative morbidity and a major cause of unanticipated admissions, we feel that the significant reduction in its incidence in the P group represents a relevant clinical advantage. Of note, we observed no significant difference between groups in administration of opioids both intra- and postoperatively. Overall, our results in both the S and the P groups compare very favorably with a published PONV incidence of 20% in ambulatory dental surgery in children (30). In this regard, we are aware that the inclusion of dexamethasone with its documented antiemetic activity into our protocol represents a confounding factor (31). Again, similar to our reasoning for allowing optional midazolam premedication, we felt that it is representative of contemporary practice to reduce gingival swelling after dental surgery (32). Previous studies have described a faster recovery time for sevoflurane anesthetics when compared to propofol. However, we feel that a difference of 10 min to reach discharge readiness, as observed in our present study, is probably of limited clinical relevance in most settings where ‘time to discharge readiness’ does not equal ‘time to actual discharge’ (15,33). In summary, propofol did not have a significant beneficial effect on emergence delirium after pediatric dental surgery when compared to sevoflurane. However, sevoflurane led to a significantly higher incidence of PONV and PACU nursing interventions. We therefore conclude that on balance propofol does offer a clinically significant advantage over sevoflurane in pediatric dental surgery.

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Funding Departmental funding.

Conflict of interest None.

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Accepted 7 May 2009



Quality of recovery from two types of generalanesthesia