Comprehensive pain management protocol reduces children’s memory of pain at discharge from the pediatric ED
American Journal of Emergency Medicine (2012) 30, 861-871
Original Contribution
Comprehensive pain management protocol reduces children’s memory of pain at discharge from the pediatric ED?
Patrick J. Crocker DO, Eric Higginbotham MD, Benjamin T. King MPH, Diane Taylor RN, Truman J. Milling Jr. MD?
Dell Children’s Medical Center of Central Texas, University Medical Center at Brackenridge, Austin, TX 78752, USA
Received 7 April 2011; accepted 25 May 2011
Abstract
Background: Historically, pain has been poorly managed in the pediatric emergency department (ED) (PED), resulting in measurable psychosocial issues both acute and delayed.
Objective: The aim of the study was to measure the impact of protocolized pain management on patients with painful conditions or undergoing painful procedures in the PED.
Methods: We performed an analysis before and after the implementation of the protocol, dubbed the “Comfort Zone.” Validated, age-appropriate pain scales were performed. Validation (using Cronbach ?, confirmatory factor analysis) was followed by comparison of responses between the pre- and posttests collected (?2 and Wilcoxon rank sum tests). Pain scores were collected at triage and at discharge. At triage, patients were asked to report pain levels. At discharge, they were asked to report their current pain and recall the level of pain during their stay. At triage, parents were asked to report about their perception of the child’s pain. At discharge, they were asked to report about their perception of the child’s current pain and recall the level of pain during the stay and during procedures, if done.
Results: Five hundred thirty-one patients were enrolled in the preprotocol group; 47% were women with a median age of 5 years (range, 30 days-18 years). Two hundred sixty-three patients were enrolled in the protocol group; 39% were women with a median age of 6 years (range, 30 days-18 years). Patient- recalled pain scores of the ED visit in the protocol group were significantly lower than those of the preprotocol group (Wong-Baker Faces Pain Scale, 5.07-4.01; P b .001); yet parent estimates of pain did not show a significant change at any point. Patient assessment of pain at ED discharge did not show a significant change either (Wong-Baker Faces Pain Scale, 1.99-1.56; P = .09). The Faces scale is not well validated for patients younger than 4, so that group had only parental assessment of pain and, consistent with the larger data set, showed no significant pain scale reduction at any point.
Conclusion: Protocolized pain management reduces patients’ memory of pain during PED visits but may not affect parental memory of perceived pain or parent- and patient-reported pain at discharge.
(C) 2012
? This study was partially funded by a grant from the Dell Children’s Foundation.
* Corresponding author. Tel.: +1 512 610 0370, 347 401 3008 (Cell); fax: +1 512 610 0380.
E-mail addresses: [email protected], [email protected] (T.J. Milling).
0735-6757/$ - see front matter (C) 2012 doi:10.1016/j.ajem.2011.05.030
Introduction
There is a long history of inadequate anxiety and pain recognition and control in the pediatric emergency depart- ment (PED) [1-5]. This has been documented by multiple prior studies of both parent and patient perception of pain control and anxiety-alleviating measures [3,6-12]. A ratio- nale for this has been an unsubstantiated assumption that children perceive pain and anxiety differently or “won’t remember” or a failure to recognize the child-specific signs of pain. Furthermore, research exists indicating that children can have posttraumatic stress disorder symptoms after painful and stressful procedures in the PED [13]. There now exist medication and tools to reduce pain and anxiety that do not require intravenous access or Intramuscular injection. These new devices are simple to use, painless, and not threatening, and they represent a more compassionate way to treat children.
Single interventions (eg, Intranasal fentanyl or versed, isolated, distraction techniques) have shown promise in helping to ameliorate the discomfort associated with these procedures [14,15]; however, the impact of a comprehensive protocol using multiple interventions on child and parent perception of pain has not been extensively studied.
Our institution has developed a multidisciplinary, multi- faceted approach to the control of the anxiety and pain associated with painful conditions and procedures in the PED. pharmacologic interventions were used to minimize the noxious effects of procedures and painful conditions, driven by child- and parent-reported Wong-Baker Faces pain scales [16], and were begun in triage.
The goal of this investigation was as follows: our institution gauged the effect of this protocol by measuring patient and parent pain scores before and after implementation.
Study methods
This study was exempted from review by the Seton Institutional Review Board.
Setting was a dedicated children’s hospital, Dell Chil- dren’s Medical Center, Austin, TX, with an annual PED volume of 70 000 visits.
Protocolized Pain Management Intervention “Comfort Zone” protocol: The emergency department (ED) imple- mented a process for creating a team approach to address pain, anxiety, and discomfort associated with the treatment for pediatric patients in the emergency setting. This program crosses many disciplines, as numerous and various levels of professionals are frequently involved in the Delivery of care to children in the department. Efforts were made to increase pain management awareness with techniques woven into the fabric of the ED via education; protocols; and, importantly, changes in attitudes toward pain control. Collectively, this process
is referred to as the “Comfort Zone” (CZ) (for protocol, see Fig. 1).
Comfort Zone goals are to
-
- make pain management a fundamental component of care, working with families to evaluate promptly and treat effectively;
- provide education and training regarding pain manage- ment to patients, families, the public, hospital staff, and the medical community in delivering evidence-based care;
- implement specific guidelines, centered on a holistic approach, using state-of-the-art techniques, both pharma- cologic and nonpharmacologic methods; and
- monitor and implement quality improvement plans to ensure optimal pain management.
Wong-Baker Faces and parental scales were collected at triage and drove the initial interventions (see Fig. 1). A patient Satisfaction survey, including the Wong-Baker Faces and the parental scales specifically targeting the clinical management of pain in the emergency setting, was gathered at discharge before and after implementation of the new pain protocol to assess the impact of the CZ on parent and patient perceptions of pain (Fig. 2).
A retrospective review of the surveys described was used to gauge patient and parent satisfaction related to pain control measures taken. The survey assessed general and specific attitudes about the care provided and satisfaction with the CZ efforts to control the patient’s pain. It used an 11-point scale (0-10) to gather parent/guardian assessments of pain and an 11-point (0-10) 6-face scale, previously adapted from the Wong-Baker Faces Pain Rating Scale for clinical pain assessments in the PED, to gather patient assessments of pain during different stages of treatment. The face scale used in the survey has been validated in the PED [17] following the original Wong-Baker [16] and was the common tool used by staff in the PED before implementation of the CZ. Emergency department staff was instructed to collect the surveys on all patients older than the age of 30 days with a painful condition, injury, or procedure. The parent/guardian and patient had to agree to participate in the survey and had to be able to understand the survey questions and respond verbally. The survey was available in Spanish and English. Patients aged 4 years and older self-reported Faces scale pain. Patients younger than 4 years had only parental- reported pain scale and, thus, were analyzed with the parental pain scores group.
Extensive nursing and physician education was provided regarding the implementation of the pain protocol. In addition, nurses and child life specialists were trained by a nurse education staff to administer the survey and collect the information reliably and uniformly. The purpose for the evaluation, survey eligibility criteria, proper documentation of responses, and how to handle and process the surveys at the end of a visit were addressed.
pediatric pain MANAGEMENT PROTOCOL EMERGENCY DEPARTMENT
Addressograph
Pt. Name Age Sex
Patient # Site
Date: Time: Wt: Kg Ht: cm
ALLERGIES and REACTIONS: ITEMS WITH BOXES MUST BE CHECKED TO BE ORDERED
MEDICATIONS:
Formulary substitutions acceptable as approved by the Pharmacy and Therapeutics committee. Generic equivalents may be used.
PAIN SCORE 1 - 2:
Non-Pharmacologic:
Reposition, Splint, Heat/Cold, Pacifier/Sweetease, Childlife Consult
Topi cal:
Lidocaine 4% topical cream (L-M-X(TM)) - apply to affected area x 1 dose
LAT G el (Lidocaine-Adrenaline-Tetracaine) - apply to affected area x 1 dose
PAIN SCORE GREATER/EQUAL TO 3:
Oral Analgesics:
Acetaminophen (Tylenol(R)) mg (15 mg/kg/dose) PO/PR every 4 hours PRN mild pain (not to exceed a maximum of 90 mg/kg/day from all sources).
Ibuprofen (Motrin(R)) mg (10 mg/kg/dose) PO every 6 hours PRN mild pain (not to exceed a maximum of 40 mg/kg/day).
Adolescents (greater than 44 kg) Oral Analgesic:
Acetaminophen (Tylenol(R)) 650 mg PO every 4 hours PRN mild pain (not to exceed 4 grams/day all sources)
Ibuprofen (Motrin(R)) 400 mg (weight: 44 kg - 60 kg) PO every 6 hours PRN mild pain (not to exceed 3.2 grams /day)
Ibuprofen (Motrin(R)) 600 mg (weight greater than 60 kg) PO every 6 hours PRN mild pain (Not to exceed 3.2 grams /day)
***For children less than 12 yrs, do not to exceed 5 doses/day of acetaminophen or children greater than 12 yrs, do not to exceed 4 grams of acetaminophen/day. Consider acetaminophen from all sources***
PAIN SCORE 4 - 7: CONSULT PHYSICIAN PRIOR TO ADMINISTRATION OF MEDICATIONS
Oral Analgesic:
Hydrocodone/acetaminophen elixir (Lortab(R)) mL (0.2 - 0.4 mL/kg provides 0.1 - 0.2 mg/kg/dose of hydrocodone) PO every 4 hours PRN moderate - severe pain.
(Formulated as 0.5 mg hydrocodone and 33.4 mg acetaminophen per mL.)
Acetaminophen/codeine elixir (Tylenol with Codeine(R)) mL (0.2 - 0.4 mL/kg provides 0.5 - 1 mg/kg/dose of codeine) PO every 4 hours PRN moderate - severe pain.
(Formulated as 2.4 mg codeine and 24 mg acetaminophen per mL.)
Fig. 1 Dell children’s protocol.
PEDIATRIC PAIN MANAGEMENT PROTOCOL EMERGENCY DEPARTMENT
CONSULT PHYSICIAN PRIOR TO ADMINISTRATION OF MEDICATIONS
Adolescents (greater than 44 kg) Oral Analgesic:
Intranasal Analgesic:
Fentanyl mcg (2 mcg/kg/dose; usual max = 100 mcg/dose) intranasal x 1 dose
Adolescents (greater than 44 kg) IV Analgesic :
Morphine mg (0.05 - 0.1 mg/kg/dose) IV every 2 hours PRN moderate - severe pain
Morphine mg (0.1 mg/kg/dose) IV every 1 - 2 hours PRN severe pain
TREATMENT OF side effects:
Nausea: Ondansetron (Zofran(R)) mg (0.1 mg/kg/dose; max = 4 mg/dose) IV every 12 hours PRN
EMERGENCY REVERSAL:
Naloxone (Narcan(R)) mg (0.01 mg/kg/dose) IVP every 5 minutes PRN until condition reversed
(Maximum Cumulative dose = 0.4 mg)
Intranasal Anxiolytic:
Fig. 1 (continued)
Fig. 2 Survey and pain assessment tool.
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7. I ann sati.st”ied with the efforts tti contrtil my child’s pain.
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S. 1 ann salisficd with the plan to control my child’s pain oncc wc lcavc the
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II. FOR PARENTS / GUARDIANS OF PATIENT — TO BE COMPLETED BY NURSE:
Nurses: this is an eva1uatit>n
Verv Dissatisiied Dissatisfied Neutral Satisfied Ve rv Satisiied N/A Complications”
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II. FOR PATIENTS AGE 4 & OLDER — TO BE COMPLETED BY NURSE OR CHILD LIFE SPC:
Fig. 2 (continued)
Fig. 2 (continued)
The survey was collected by a single staff alone or by 2 staff working in tandem with the patient and the parent/ guardian. The staff members collecting the survey were an ED nurse, a child life specialist, or both. Child life specialists are staff professionally trained to help reduce stress and anxiety that children and their families may encounter because of illness, injury, and hospitalization. If both the child life specialist and nurse or 2 nurses are involved in the survey collection simultaneously, the staff working with the pediatric patient used the face scale image available on their employee badges to combine all responses onto a single form.
Although the actual sample size was based on the number of evaluations performed during the two 6-week periods selected, the planned sample size targeted for evaluation was performed using a minimum expected difference of 0.1 on the 6-face scale, an estimated SD of
0.3 on mean responses, and a 2-tailed ? = .05 and ? = .2 that required a minimum of 142 surveys per subject group. More than this number of surveys was collected during each phase of survey collection, allowing for the analysis planned by this study. Overall satisfaction score (OSS) was calculated in the database and was used, in addition to parent and patient assessments of pain during and after their visit, as outcome measures. Overall satisfaction score is
calculated as the sum of the eight 5-point scale lead questions on satisfaction. Table 1 lists evaluation tool itEMS used to collect data on subjects.
Before hypothesis testing, reliability of the evaluation tool was tested with a Cronbach ? test on each of the 4 sections of the survey because independent sources are solicited in various sections (parent, patient, treating nurse). content validity was tested with a principal component factor analysis to identify and test for the suspected existence of a specific directional correlation and single-factor grouping.
The primary outcome variables of overall satisfaction and targeted pain assessments were tested for differences from pre- and post-CZ intervention. Overall satisfaction, individ- ual satisfaction item scores, and the 11-point pain assess- ments were tested for changes using nonparametric Wilcoxon rank sum tests.
Results
Five hundred thirty-one patients were enrolled in the preprotocol group (PPG); 47% were women with a median age of 5 years (range, 0-18 years). Two hundred sixty-three patients were enrolled in the protocol group (PG); 39% were women with a median age of 6 years (range, 0-18 years).
Table 1 Pain management and patient satisfaction
Baseline Midpoint Rank sum
n = 531 n = 263 P
Mean (CI) Mean (CI)
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Parent questionnaire
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Q1 |
4.62 (4.56-4.68) 4.66 (4.57-4.75) |
.090 |
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Q2 |
4.57 (4.51-4.63) 4.57 (4.48-4.67) |
.684 |
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Q3 |
4.78 (4.73-4.83) 4.75 (4.67-4.83) |
.978 |
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Q4 |
4.71 (4.66-4.77) 4.71 (4.63-4.79) |
.796 |
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Q5 |
4.72 (4.67-4.77) 4.72 (4.64-4.80) |
.650 |
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Q6 |
4.68 (4.62-4.74) 4.67 (4.58-4.76) |
.937 |
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Q7 |
4.64 (4.59-4.70) 4.69 (4.60-4.77) |
.216 |
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Q8 |
4.63 (4.57-4.69) 4.66 (4.57-4.75) |
.258 |
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Parent pain estimate |
11-point Likert |
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Before |
6.02 (5.77-6.27) 6.18 (5.82-6.55) |
.734 |
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During visit |
4.98 (4.74-5.23) 4.90 (4.54-5.25) |
.403 |
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Procedure |
4.16 (3.89-4.42) 3.86 (3.49-4.24) |
.111 |
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After |
2.15 (1.95-2.35) 1.85 (1.60-2.10) |
.176 |
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Item-specific evaluations |
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EMLA/L-M-X (lidocaine 4%) |
4.63 (4.26-5.00; 19) 4.64 (4.43-4.84; 44) |
.984 |
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(n = 63) |
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Bionox (n = 8) |
5 (5-5; 2) 4.50 (3.62-5.38; 6) |
.383 |
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Nitrous oxide (n = 6) |
5 (5-5; 1) 4.40 (3.29-5.51; 5) |
.488 |
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Ketamine (n = 27) |
4.78 (4.44-5.12; 9) 4.11 (3.43-4.79; 18) |
.207 |
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Child life specialists (n = 154) |
4.55 (4.38-4.72; 85) 4.59 (4.36-4.83; 69) |
.148 |
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IV meds (n = 83) |
4.66 (4.43-4.89; 44) 4.69 (4.42-4.96; 39) |
.477 |
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Non-steroidal anti-inflammatory |
4.60 (4.47-4.72; 132) 4.46 (4.19-4.73; 50) |
.541 |
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drugs (n = 182) |
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Oral narcotics (n = 46) |
4.62 (4.33-4.90; 26) 4.90 (4.76-5.04; 20) |
.089 |
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Ice and elevation (n = 63) |
4.60 (4.41-4.79; 45) 4.44 (3.96-4.93; 18) |
.703 |
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11 pt / 6 face Baker Wong Faces Pain Scale |
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Pediatric self-report face scales |
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Before |
6.77 (6.46-7.09) 6.47 (6.01-6.94) |
.414 |
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During |
5.07 (4.76-5.39) 4.01 (3.64-4.39) |
b.001* |
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After |
1.99 (1.74-2.24) 1.56 (1.29-1.83) |
.092 |
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Demographics |
Total PPG |
PG |
P |
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Sex |
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Male (%) |
55.3 52.7 |
60.7 |
.035* |
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Female (%) |
44.7 47.3 |
39.3 |
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Age, y (median) |
6 5 |
6 |
.044* |
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Sex |
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M (P) F (P) |
Total (rank sum P) |
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OSS Parent-reported pain before Parent-reported pain during Parent-reported pain during a procedure Parent-reported pain after Patient-reported pain before Patient-reported pain during Patient-reported pain after |
.619 .858 |
.522 |
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.766 .650 |
.639 |
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.923 .038* |
.237 |
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.565 .370 |
.302 |
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.685 .297 |
.414 |
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.002* .007* |
b.001* |
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.567 .134 |
.092 |
Table 1 (continued)
Means Pre, Parent-reported
pain during a procedure
Post, Parent-reported pain during a procedure
Change in score Total (mean) Rank sum P
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Male |
4.05 |
4.05 |
-0.00 |
4.05 |
.923 |
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Female |
4.31 |
3.54 |
-0.77 |
4.10 |
.038* |
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Total |
4.16 |
3.86 |
-0.39 |
4.06 |
.237 |
*: statistical significance EMLA, eutectic mixture of local anesthetic. L-M-X, topical lidocaine 4%; NO, nitrous oxide; CLS, Child life specialists; NSAIDs, Nonsteroidal antiinflammatory drugs.
Testing of the survey itself demonstrated it to be a reliable (Cronbach ? = .96, within-section Pearson Correlation coefficients N0.6) measurement tool. internal validity testing with principal component factor analysis grouped items around single factors with eigenvalues greater than 0.8 for each response section of the survey.
Patient-recalled pain scores in the PG were significantly lower for during the ED visit than that for the PPG (Baker- Wong Faces Pain Scale, 5.07-4.01; P b .001); yet parent- recalled pain estimates for during the ED visit in PG only trended in that direction and did not attain significance. The same nonsignificant downward trends in assessment changes were seen at ED discharge both by the patient (1.99-1.56) and parent (2.15-1.85) and in parent assess- ment during procedures (4.16-3.86). The PG contained significantly more men (61% vs 53%, P = .035) and was slightly older (6 vs 5 years, P = .044). No differences between sexes were identified in changes in assessment scores, except for the parent-recalled assessment of pain during procedures for which assessed pain level decreased significantly for female patients (P b .05) but not for male patients. The PPG had less typically painful conditions (fractures, dislocations, sprains, contusions, lacerations, and abscesses) (34% vs 50%, P b .05). No other measured variables attained significance.
Limitations
Although we have a protocol, a group of interventions that together reduce child pain, we cannot distinguish to what degree each intervention individually affected pain reduc- tion. This would be an area for further study.
Logistically, we were only able to collect the pain scores at 2 time points, that is, triage and discharge, and this required patients and parents to recall pain levels during their stay, so the data are subject to recall bias. However, this bias would have had the same effect in both the PPG and PG and thus should not be confounding. We therefore have shown a reduction in the child’s recall or memory at discharge of pain during ED stay, arguably more important than a reduction measured contemporane- ously with treatment, as it is the memory of pain that correlates with negative short- and long-term outcomes [18-21].
We have unbalanced comparison groups (531 PPG vs 263) because the H1N1 influenza epidemic struck toward the end of our study period and because the overwhelming patient load shut down research operations. This was a retrospective, observational, nonrandomized study and has the associated limitations of that design, such as documentation errors, missing data values, and other. The study’s pre-post design was chosen to best mimic real-life clinical situations and because randomization was not feasible or practical.
We do not believe that the Hawthorne effect was a confounder as we were studying patient pain scores before and after implementation of the protocol.
Chance dealt us a slightly different demographic for the PG, that is, slightly older with more men and more typically painful conditions. However, age only correlated signifi- cantly with the triage and discharge pain assessments, that is, older patients reported higher pain scales, not the recalled during visit pain, and thus, it does not confound our primary finding. Furthermore, a logistic regression controlling for the variables age and sex did not alter the results. Regarding the difference in typically painful conditions, this would seem to reinforce the primary finding if there was more aggregate pain in the PG, although the similar triage pain scores in the 2 groups would seem to indicate that the types of conditions did not impact the degree of pain in the 2 populations, and thus, it does not confound.
Discussion
The appropriate treatment for acute painful conditions and the management of procedure-related pain in children has long been a topic of study and practice criticism [2,3]. Prior studies have reported the failure to use analgesics at all in some cases, late administration of analgesics, improper selection of analgesic, and inadequate dosing [1,5]. Studies have found that children are less likely than adults to receive analgesia for extremity fractures in the ED [4].
The failure to adequately address pain and anxiety in children is not without consequences to the patient. The literature is now populated with studies demonstrating the potential for long-term consequences of painful and anxiety- provoking procedures [22-30]. Undergoing painful procedures contributes to children’s fear of physicians, nurses, and
hospitals in the future and likely makes subsequent procedures more difficult [29]. Such patient fears may also contribute to future Delayed presentations of other Acute conditions [29].
There have been studies assessing Analgesia provision rates in nursing vs physician-driven protocols [31], but we are aware of no global pain management protocol involving the entire health care team and bundling the available best practices and methods that has been shown to reduce pediatric pain in the ED on a validated pain scale. We see this as akin to the approach to sepsis in the early goal-directed therapy paradigm set out in the landmark study by Rivers et al [32], although that study was randomized and ours is a before and after model. Although we cannot, from this study, be sure which elements of the protocol play the major role in pain reduction, we can say that the protocol, in its entirety, is the first to definitively show a reduction in recalled pediatric pain in the ED.
The finding that parental assessment of pain was unchanged is consistent with prior studies that have noted that parents and health care providers are poor judges of children’s pain [33-35].
In implementing our CZ protocol, the reeducation of both the nursing and medical staff around the topics of pain recognition, the consequences of pain and anxiety, and the mythology around children’s perception of pain played a central and necessary role but are more difficult to quantify. Our trial used a multidisciplinary and multifactorial approach to pain management using simple-graded in- terventions in response to the perceived pain reported by the child and/or parent. The stepwise-graded response to pain and anxiety initiated in triage can avoid delays in care when incorporated into the routine pattern of care. Newer pharmacologic agents such as effective topical skin anes- thetics (Eutectic Mixture of Local Anesthetic cream (Eloquest Healthcare, Ferndale, MI) and PainEase (Gebauer Co., Cleveland, OH)) and tools such as the Mucosal Atomization Device (Wolfe Tory Medical, Inc., Salt Lake City, UT) allow for provision of significant pain and anxiety controls in a timely fashion without the use of intramuscular
injections or the need for intravenous access.
In our study, we observed no significant oversedation at protocol doses even when medications were used in combination, and there was no requirement to use reversal agents. Patients given the intranasal drugs remained awake and fully responsive and were ready for discharge immediately after procedures. The implementation of such measures now readily available, nonthreatening, and effective represents a more compassionate way to treat children and can improve patient perceptions and simplify care.
Conclusion
We have demonstrated an effective protocol to reduce the remembered perception of pain by children undergoing painful procedures or having painful conditions in the PED.
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