Assessment of Sedation Levels in Pediatric Intensive Care 48tn3rsb7o
Assessment of Sedation Levels in Pediatric Intensive Care 48tn3rsb7o
Objectives: The original COMFORT scale, including both obser- Interpretation Score of Sedation scores were obtained in 78
vational and physiologic items, has been validated for measuring patients. Cronbach’s alpha for the COMFORT scale was .78, in-
distress in children admitted to a pediatric intensive care unit. creasing to .84 when the physiologic items, blood pressure and
However, physiologic variables are influenced by drugs given in heart rate, were excluded. COMFORT scores were significantly
the pediatric intensive care unit setting. The objectives of this different for the three Nurse Interpretation Score of Sedation
study were to assess the usefulness of physiologic variables in categories (Kruskal-Wallis, p < .001). According to the pediatric
judgment of sedation and to determine new cutoff points for the intensive care unit nurses, undersedation was present in 11% and
COMFORT “behavioral” scale (COMFORT-B), using only observa- oversedation in 3% of all observations. Cutoff points for the
tional items. COMFORT-B scale were <10 for oversedation and >23 for un-
Design: Prospective observational study. dersedation. The area in the COMFORT-B score between 11 and 22
Setting: Pediatric intensive care unit in a university hospital does not adequately predict under- or oversedation, pointing to a
Patients: Seventy-eight patients admitted to the pediatric in- need for supplemental observation.
tensive care unit. Conclusions: The COMFORT-B scale is a reliable alternative to
Interventions: None. the original COMFORT scale. The cutoff points of the COMFORT-B
Measurements and Results: COMFORT scores were obtained in scale in conjunction with the Nurse Interpretation Score of Seda-
this patient group. Similar to the original COMFORT scale valida- tion facilitate the use of sedation algorithms on the pediatric
tion, the expert opinion of nurses (Nurse Interpretation Score of intensive care unit. (Pediatr Crit Care Med 2005; 6:58 –63)
Sedation) served to determine optimal cutoff scores for the COM- KEY WORDS: sedation; pediatric; COMFORT Scale; pediatric in-
FORT-B scale. A total of 843 combined COMFORT and Nurse tensive care unit; critical care; comfort; assessment; critically ill
C ritically ill children admitted The Ramsay scale is the sedation scor- implies that the COMFORT scale can be
to a pediatric intensive care ing system most used in the adult inten- used in both ventilated and nonventilated
unit (PICU) will experience sive care setting (6). Several categories in pediatric patients (7, 11). The University
physical and psychological this scale are based on judgment of level of Michigan Sedation Scale is restricted
discomfort (1, 2). Apart from discomfort, of consciousness. Other Ramsay scale to level of consciousness and has only
stress is a well-recognized negative factor categories, such as response to com- been validated for short, procedure-
in determining the speed of recovery in mands, are not relevant for young in- related observations (9). Because comfort
children (3). Both factors warrant ade- fants. This calls for other, more specific in children has many more aspects than
quate sedation and pain relief in this vul- observations in the PICU setting. Con- consciousness alone, and preverbal in-
nerable patient group (4, 5). trary to adult intensive care, no gold fants are not able to clearly communicate
Although clinical judgment of trained standard for sedation is available for PICU discomfort, it is necessary to include
PICU nurses and physicians is important, use (7). Several sedation scoring scales other behavioral and physiologic vari-
the development of an optimal scoring have been described for children (Table ables. An additional advantage of the
system for sedation is needed to both 1): the Hartwig Sedation Scale (8), the COMFORT scale is that it takes these
determine the efficacy of sedatives and COMFORT Scale (1), the University of variables into account.
related interventions and facilitate inter- Michigan Sedation Scale (9), and recently Although the COMFORT scale was
institutional comparisons. one for neonates (Neonatal Pain, Agita- originally described in and validated for
tion, and Sedation Scale) (10). All these measuring discomfort in ventilated pedi-
scales have been validated by comparison atric patients, the use of this instrument
with the “expert opinion” of attending in the clinical PICU setting is disputed (1,
*See also p. 91. physicians and/or nurses, and each has its 12). The correct use of the physiologic
From the Departments of Pediatrics (EI, MdH) and specific strengths and weaknesses (Table variables of the COMFORT scale implies
Pediatric Surgery (MvD, DT), Erasmus MC/Sophia Chil-
1). At present, the COMFORT scale seems that reference values for heart rate and
dren’s Hospital, Rotterdam, The Netherlands.
Copyright © 2005 by the Society of Critical Care to be the most practical scoring system arterial blood pressure are adjusted each
Medicine and the World Federation of Pediatric Inten- for PICU use. In contrast to the Hartwig day. Because these physiologic variables
sive and Critical Care Societies scale, the COMFORT scale does not use are titrated by inotropic and other drugs
DOI: 10.1097/01.PCC.0000149318.40279.1A reaction to suctioning as an item. This often used in pediatric intensive care, we
Conditions Measured
questioned whether their use contributes atric patients in a PICU environment and has or changed. Individual baseline values for
to the overall assessment of sedation in also been validated to assess postoperative heart rate (HR) and mean arterial blood pres-
the individual patient. It has already been pain in children ⬍3 yrs of age (1, 13). The sure (MAP) were calculated each day. Severity
demonstrated that these two variables behavioral items are alertness, calmness, re- of illness was scored using the Pediatric Index
spiratory response (in ventilated patients) or of Mortality score (16).
have a low interrater agreement (1). Two
crying (in nonventilated patients), muscle
other studies have demonstrated insuffi- tone, physical movement, and facial tension. It
cient correlation between physiologic and contains two physiologic items, heart rate and Interobserver Reliability
behavioral COMFORT items (13, 14). mean arterial pressure, the latter requiring an All nurses at the PICU were trained to use
We set up a study with a two-fold indwelling arterial catheter. the COMFORT scale by using both videotaped
objective. The first objective was to assess All response categories range from 1, “no material and bedside instructions. Newly
whether physiologic variables are really distress,” to 5, “severe distress.” The COM-
trained nurses performed ten COMFORT as-
useful in the judgment of sedation with FORT scale has been officially translated into
sessments together with a trained nurse.
the COMFORT scale, and second, we Dutch and adapted to the extent that the item
When the obtained linearly weighted Cohen’s
aimed at determining cutoff points for an “crying” was added for nonventilated patients
(13). kappa was satisfactory (⬎.65) (17), nurses
abbreviated COMFORT scale restricted to could participate in the study. The median
behavioral COMFORT items (the COM- interobserver-reliability linearly weighted Co-
FORT-B scale). Nurse Interpretation of Sedation hen’s kappa in our PICU was 0.84 (range,
Score (NISS) .67–.96) for 52 nurses.
MATERIALS AND METHODS In a random sample of this study, a second
To facilitate a comparison between the
nurse performed a COMFORT score at the
COMFORT scale and the clinical judgment of
Design same time as the attending nurse. This test
the attending nurse, we used a reference
served to check whether the COMFORT score
Prospective observational study. score, similar to the one used in the original
was influenced by the fact that the attending
validation by Marx et al. (12). The NISS is the
nurse had already performed a NISS score.
Patients nurse’s expert opinion of the level of sedation,
reflected by one of these categories:
Children aged 0 –18 yrs admitted to the Sedation Medication
PICU of the Erasmus MC–Sophia Children’s 1. Insufficient sedation
Hospital between March 2002 and November 2. Adequate sedation Administration of sedative drugs was at the
2002 were eligible for this study. Children 3. Oversedation discretion of the attending physician. The
with severe mental retardation, severe hypo- drug of first choice for sedation purposes in
tonia, and neuromuscular blockade were ex- Using the expert opinion of a professional our PICU is midazolam (0.05– 0.3 mg/kg/hr).
cluded because the COMFORT scale has not is common practice for validation of scales like When sedation is considered insufficient, mor-
been validated for these patients. Patients were the COMFORT Scale. Expert opinion can be phine, ketamine, or fentanyl is given in addi-
included when at least one of five study nurses viewed as the “silver standard” when a “gold tion to midazolam. Other drugs are used very
was on call to coordinate data sampling. Be- standard” is not available (15). infrequently.
cause of the strictly observational and nonin-
vasive nature of the study, the institutional Procedure/Measurement Statistical Analysis
review board waived the need for informed
consent. The care-giving nurse assessed the patient Interrater reliability was tested by using
every 8-hr shift at set times (2, 10, and 18 hrs) the linearly weighted Cohen’s kappa and the
determining the NISS score before COMFORT intraclass correlation coefficient.
Measurements
score. Paired scores were obtained when the The internal consistency was calculated by
COMFORT Scale. The COMFORT scale was patient was uncomfortable (NISS ⫽ 1) or using Cronbach’s alpha, a reliability index that
originally developed to assess distress in pedi- when sedation medication was administered estimates the internal consistency of several
Table 2. Background characteristics of the pa- Table 3. Sedatives and analgesics use for patient group (n ⫽ 78)
tient group (n ⫽ 78)
Medication No. % Doses, Median (Range)
Variable No. %
Sedatives
Gender Midazolam 65 83.3 100 g/kg/hr (50–900)
Male 49 63 Ketamine 11 14.1 1 mg/kg/hr (1–4)
Female 29 27 Analgesics
Age group Morphine 31 39.7 15 g/kg/hr (5–40)
Neonate 12 15 Fentanyl 4 5.1 1 g/kg/hr (1–2)
1–6 mos 14 18
6–12 mos 11 14
1–3 yrs 17 22
⬎3 yrs 24 31 Table 4. Corrected item-total correlation (n ⫽ 596 observations)
Diagnosis
Cardiac—congenital 15 19 Corrected Item-Total
Cardiac—others 3 4 COMFORT Scale Item Correlation Alpha If Item Deleted
Respiratory failure 26 33
Sepsis, septic shock 14 18 MAP .27 .80
Other diagnosis 20 26 HR .31 .79
PIM score Alertness .60 .74
Mean 0.13 Calmness .65 .74
Median 0.07 Respiratory response or crying .48 .76
Range (minimum, 0.002–0.96 Physical movement .71 .72
maximum) Muscle tone .43 .77
No. of ventilated patients 66 85 Facial tension .54 .76
PIM, Pediatric Index of Mortality. MAP, mean arterial pressure; HR, heart rate.
6 11 1.3 1.3
7 38 4.5 5.8
8 60 7.1 12.9 0 (0.0) 302 (41.9) 27 (93.1)
9 128 15.2 28.1
10 99 11.7 39.8
23 5 0.6 98.2
24 5 0.6 98.8
25 3 0.4 99.2
26 2 0.2 99.4
27 3 0.3 99.7 18 (19.3) 8 (0.1) 0 (0)
28 0 0.0
29 1 0.1 99.8
30 0 0.0
COMFORT and NISS Scores vations during the day and 9.8% of ob- low values when baseline values were in-
servations during the night. The median creased due to stress, and second, the
Patients were considered adequately COMFORT-B scores of 78 patients were 15% increase has to our knowledge never
sedated (NISS ⫽ 2) in 721 (86%) of all significantly higher during daytime than been tested for adequacy. Additionally,
observations. In 63% of these observa- during nighttime (Wilcoxon test, Z ⫽ only low correlations of HR and MAP with
tions, the COMFORT score pointed at ad- ⫺2.86, p ⫽ .004). the other items of the COMFORT scale
equate sedation. were seen.
Patients were considered oversedated DISCUSSION Exclusion of these physiologic items
(NISS ⫽ 3) in 29 observations in 18 pa- in the present study increased the reli-
tients. In 91% of these observations, the The main findings of this study are
ability of the total COMFORT score.
COMFORT score also implied overseda- two-fold. First, physiologic variables do
These findings are in line with those
tion. Patients were considered underse- not correlate well with the behavioral
from two other studies (13, 14). The
dated (NISS ⫽ 1) in a total of 93 (11%) items of the COMFORT scale. Second,
study by Carnevale and Razack (14) in
observations in 35 patients. In 78.3% of there is a definite gray area, with COM-
these observations, the COMFORT scale FORT-B scores of ⱖ11 and ⱕ22, where 18 pediatric patients indicated that
also implied undersedation. These 35 adequate sedation cannot be based on physiologic variables have a very lim-
(NISS ⫽ 1) and 18 (NISS ⫽ 3) patients COMFORT-B scores alone. ited validity as determinants of the total
did not differ significantly from the total Our results show a low variance of the COMFORT score. In a former study in
study group with regard to age, diagnosis, MAP and HR items, because these vari- postoperative patients (0 –3 yrs), we
gender, or Pediatric Index of Mortality ables are by nature artificially controlled demonstrated insufficient correlation
score. in the PICU. Another explanation for the between physiologic and behavioral
Some differences between daytime ob- low variance in the HR and MAP items COMFORT items, indicating that inclu-
servations (6 am until 10 pm, n ⫽ 546) may be due to the construction of these sion of physiologic variables was not
and nighttime (n ⫽ 297) observations two items within the COMFORT scale. useful (13). The surplus value of this
were observed. Oversedation (NISS ⫽ 3) The HR and MAP scores are compared study compared with the study of
occurred in 4.4% of daytime and 1.7% of with baseline values. HR and MAP are Carnevale and Razack lies in the greater
nighttime observations. Undersedation scored ⬎1 when these items are 15% sample size and the determination of
(NISS ⫽ 1) was seen in 11.7% of obser- above baseline. First, this may result in cutoff points for the COMFORT-B scale.
O
clinical judgment of sedation. A COM- FORT-B scores, where the overall impres-
FORT scale restricted to behavioral items sion of the attending nurse is different. ur results indi-
needs new cutoff points. In the present Factors such as day-night rhythm and
cate that the as-
study, as in the original study by Marx et procedure-related discomfort have to be
al. (12), we used the expert opinion of taken in to account as well. sessment of se-
experienced medical personnel, trans- Daytime COMFORT-B scores in the
lated to a 3-point scale, to validate the present study were significantly higher dation levels in children
COMFORT-B scale (1). Marx et al. origi- than nighttime scores. This finding
nally used a 5-point scale, later also re- might be explained by other factors than admitted to a pediatric in-
duced to 3 points. Since the COMFORT day-night rhythm alone. At nighttime tensive care unit can be im-
score obtained by the attending nurse there are fewer nursing and medical staff
might be biased, a second COMFORT present. Light and noise are reduced, and proved by using a COMFORT
score was performed in a subset of obser- the children receive only necessary care
vations. As shown in the results, no bias and interventions. behavior scale, leaving out
was detected. We realize the fallibility of Overall, COMFORT-B scores are rela-
using the nurse’s opinion (NISS) as the tively low in this PICU sample, consider-
physiologic variables.
gold standard. There is no true gold stan- ing the median score of 11 and bearing in
dard to compare the COMFORT against. mind that, theoretically, the COM-
Self- report is either not possible or not FORT-B score may range from 6 to 30.
reliable in young children. We are, how- These low scores may be attributed to question remains how this sedation scale
ever, confident that the NISS is useful as increased use of sedatives in pediatric in- can be used in daily practice. Can an
a silver criterion (15). Nurses were not tensive care patients. The attention for adequate sedation algorithm be devel-
only experienced but also trained in com- optimal sedation is perhaps also reflected oped solely on the basis of the COM-
fort and pain assessment. The NISS inte- in the exceptionally low percentage of FORT-B scale? Is there room for the clin-
grates personal knowledge of the attend- observations with oversedation (3.4%) by ical judgment of the attending physician
ing nurse on previous hours, illness, the PICU nurses. This low percentage and nurse in such a protocol? The use of
medication, idiosyncratic behavior, venti- might be related to the fact that in a PICU sedation observation scales, such as the
lation, and other PICU aspects of the environment, care givers do not mind COMFORT-B scale, as a single measure of
child. The NISS expert opinion is there- that infants and children are heavily se- patient sedation has drawbacks. It limits
fore only valid when applied by the care- dated with concomitant retrograde am- observation of sedation to a single point
giving nurse and is not useful when nesia for the period on the PICU. in time, without including prior knowl-
scored by an observer unfamiliar with the A second explanation for the discrep- edge of the patient. However, as long as
context of the child. ancy between an adequate NISS and low there are no methods to assess sedation
New cutoff points for the COMFORT-B COMFORT-B score in this study is the as a continuous variable, the use of a
scale were determined with an emphasis fact that all children in whom this dis- score like the COMFORT-B scale in the
on preventing undersedation. In clinical crepancy was noted were critically ill, PICU remains necessary.
practice, undersedation is a major con- with circulatory and respiratory instabil- The clinical impression of the care-
cern from the viewpoint of patients, par- ity. In these cases, the attending nurse
giving nurses (represented by the NISS)
ents, doctors, and nursing staff. Regula- might include a previous negative influ-
showed a relationship with the paired
tion of sedative medication based on ence of distress on hemodynamics and
COMFORT-B scale, albeit not a perfect
COMFORT-B scores should reflect this respiration in the judgment of the desired
one. Although it is tempting to focus on
concern. In our population, cutoff points level of sedation. An example of this phe-
the statistical significance of these find-
of 10 and 23 reached this goal. Patients nomenon was seen in patients with pul-
ings, it is more rational to admit that the
with COMFORT-B scores ⱕ10 were never monary hypertension in whom underse-
undersedated. Patients with COMFORT-B dation is a risk factor for recurrent bouts COMFORT score is fallible. We cannot
scores ⱖ23 were undersedated in 95% of of increased pulmonary resistance. Un- rely solely on an observational tool with-
cases. This means that in these ranges of dersedation according to the care-giving out prior knowledge or expertise. Even
the COMFORT-B score, changes in seda- nurses occurred in 11% of all observa- for experienced PICU nurses, though, it
tive medication can be based on the tions. This coincided with COMFORT-B remains difficult to determine the emo-
COMFORT-B score alone. With COM- scores ⬎10. tional state of their patients. Are they in
FORT-B scores ranging from 11 to 22, A limitation of this study is that the pain or distressed? Is it possible to dis-
patients had a 15.4% chance of being data were derived in one PICU with one tract the child or to apply nonpharmaco-
undersedated. The poor relationship be- set of PICU attending physicians and one logic interventions? Our findings suggest
tween the COMFORT-B score and the set of PICU nurses. There is no interna- that assessment of sedation in pediatric
clinical judgment of the nurse in this tional consensus about adequate or opti- intensive care patients could benefit from
middle COMFORT-B score range can be mal sedation. Regional and cultural atti- adding a second score such as the NISS in
explained by several factors. COMFORT-B tudes may influence the opinion about the middle range (11–22) of the COM-
scores are obtained at fixed time points optimal sedation. FORT-B score. We believe this would bet-
and do not always reflect the overall se- This study shows the feasibility of us- ter reflect the inherent difficulties and
dation of the patient over time. This ing the COMFORT-B scale in judging se- pitfalls of assessing discomfort in criti-
sometimes leads to tapering of sedation dation levels in critically ill children. The cally ill children.