Published online October 2, 2006
PEDIATRICS
Vol. 118
No. 4
October 2006, pp.
e992-e1000
(doi:10.1542/peds.2005-3203)
Assessing Postoperative Pain in Neonates: A Multicenter Observational Study
Bonnie J. Taylor, MDa,
James M. Robbins, PhDa,b,
Jeffrey I. Gold, PhDc,
Tina R. Logsdon, MSd,
T. M. Bird, MAPa,b and
K. J. S. Anand, DPhil, MBBSa,e,f,g
a Departments of Pediatrics
e Anesthesiology
f Pharmacology
g Neurobiology and Developmental Sciences
b Center for Applied Research and Evaluation, University of Arkansas for Medical Sciences College of Medicine and Arkansas Children's Hospital Research Institute, Little Rock, Arkansas
c Departments of Anesthesiology and Pediatrics, Keck School of Medicine, University of Southern California, Childrens Hospital Los Angeles, Los Angeles, California
d Performance Improvement Division, Child Health Corporation of America, Shawnee Mission, Kansas
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ABSTRACT
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OBJECTIVE. A multicenter observational study was conducted to evaluate the practices of postoperative pain assessment and management in neonates to identify specific targets for improvement in clinical practice.
METHODS. Ten participating NICUs collected data for the 72 hours after a surgical operation on 25 consecutive neonates (N = 250), including demographics, principal diagnoses, operative procedure, other painful procedures, pain assessments, interventions (pharmacologic and nonpharmacologic), and adverse events in neonates who underwent minor and major surgery. Descriptive and logistic-regression analyses were performed by using SPSS and Stata.
RESULTS. The neonates studied had a birth weight of 2.4 ± 1.0 kg (mean ± SD) and gestational age of 36 ± 4.3 weeks; 57% were male, and length of hospital stay was 23.5 ± 30.0 days. Participating hospitals used 7 different numeric pain scales, with nursing pain assessments documented for 88% (n = 220) of the patients and physician pain assessments documented for 9% (n = 23) of the patients. Opioids (84% vs 60%) and benzodiazepines (24% vs 11%) were used more commonly after major surgery than minor surgery, and a small proportion (7% major surgery, 12% minor surgery) received no analgesia. Logistic-regression analyses showed that physician pain assessment was the only significant predictor of postsurgical analgesic use, whereas major surgery and postnatal age in days did not seem to contribute. Physician pain assessment was documented for 23 patients; 22 of these received postoperative analgesia.
CONCLUSIONS. Documentation of postoperative pain assessment and management in neonates was extremely variable among the participating hospitals. Pain assessment by physicians must be emphasized, in addition to developing evidence-based guidelines for postoperative care and educating professional staff to improve postoperative pain control in neonates.
Key Words: pain newborn infant surgery premature infant quality improvement clinical audit medical effectiveness analgesia stress
Abbreviations: CHCAChild Health Corporation of America ADEadverse drug event NNPneonatal nurse practitioner ORodds ratio
Traditional medical beliefs that neonates are incapable of experiencing pain1,2 have now been abandoned. Multiple lines of evidence describe the maturation of the pain system, pain-assessment methods, and clinical consequences of pain in neonates.35 Despite this mounting evidence, neonatal pain remains an underrecognized and undertreated condition in the NICU.68 In 2000, the American Academy of Pediatrics and Canadian Paediatric Society issued a policy statement9 emphasizing the lack of awareness of neonatal pain and adverse effects of untreated pain in neonates. The American Academy of Pediatrics/Canadian Paediatric Society statement recommended consistent use of validated pain-assessment tools and therapeutic interventions (pharmacologic and nonpharmacologic) to prevent, reduce, or eliminate noxious or painful stimuli. Another consensus statement by the International Evidence-Based Group for Neonatal Pain provided guidelines for preventing and treating neonatal pain, noting the importance of pain management in neonates, regardless of gestational age or severity of illness.10 Current guidelines have not addressed postoperative pain management in neonates, and there is a minimal amount of published data to inform recommendations.9,10
Although the provision of appropriate analgesia/anesthesia for surgical procedures is well accepted in principle, the management of postoperative pain in neonates remains extremely variable,11 with wide inconsistencies in neonatal pain assessment, types of measurement tools, and pain management. To investigate further the discrepancies in neonatal pain assessment and treatment, we conducted a multicenter study of postoperative pain management in neonates who were admitted to the NICU. Our primary objectives were to (1) evaluate the methods and patterns of pain assessment and management in postsurgical newborns across 10 different institutions, gathering background data for developing standards and (2) identify specific target areas for improvements in clinical practice.
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METHODS
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Patient Selection
Twenty-five consecutive patients who were admitted to the NICU between July 1, 2002, and March 18, 2003, were enrolled at each of 10 free-standing children's hospitals that participated in a multihospital collaborative study sponsored by the Child Health Corporation of America (CHCA). Consecutive patients were studied at each participating site because of convenience and to avoid any clinical bias by excluding specific patients. Data were collected during a 72-hour period for each patient, thus involving entries by multiple physicians, nurses, and other personnel, across day and night shifts, for the 250 patients enrolled. Patients were included in the study when (1) they underwent operative surgical procedures that required anesthesiology support and monitoring either in the operating room or in the NICU and (2) were 28 to 42 weeks of gestational maturity at the time of surgery. Both intubated and nonintubated neonates were included. Patients were excluded from the study when they received neuromuscular blockade postoperatively, did not return to the NICU after surgery, were septic, or received extracorporeal membrane oxygenation.
Study Design
Each participating site obtained institutional review board approval before study participation. CHCA also obtained institutional review board approval for data management and analysis. Standardized data-collection forms that were developed by CHCA were reviewed by all study sites and pilot-tested at 2 sites. Forms then were modified on the basis of site reviews and pilot testing before formal data collection.
Data for each patient were collected by retrospective chart review for the first 72 hours after the end of a surgical operation. Data collection included patient demographics (gestational age, birth weight, and gender), principal diagnostic codes and operative procedure codes (Appendix; International Classification of Diseases, Ninth Revision codes), additional painful procedures, pain assessments, pharmacologic or nonpharmacologic interventions, analgesia and sedation orders, and adverse events related to postoperative analgesia. Investigators at 3 of the participating sites classified each surgical procedure performed on the study infants as major or minor using a modified Delphi method. The classification was intended to group patients according to the expected level of pain associated with the surgical procedure(s) and was based on invasiveness, anesthesia time, and level of tissue manipulation. Major surgical procedures were more invasive (eg, laparotomy, thoracotomy), involved protracted anesthesia time and/or involved extensive tissue manipulation, such as diaphragmatic hernia repair or intestinal resection after necrotizing enterocolitis. Minor procedures were less invasive, of shorter duration, and more localized, such as an inguinal hernia repair or circumcision. A complete list of procedures and their classification are listed in the Appendix. All adverse drug events (ADEs) associated with pain medications also were noted during chart review. ADEs were classified uniformly at all sites using the severity system of the National Coordinating Council for Medication Error Reduction and Prevention. Only ADEs of severity E and greater were included, which are defined as "patient harm that required treatment or intervention, resulted in initial or prolonged hospitalization, caused permanent harm, resulted in a near-death event, or resulted in patient death."
Statistical Methods
Completed data-collection forms were submitted to CHCA for analysis. The data were entered into a computerized database (ResearchBase; Clinical Data Management, Evergreen, CO) by trained staff, followed by detailed electronic editing and formalized data screening. Electronic edit checks were conducted on key data elements, and exceptions were reviewed and resolved by the study sites. The ResearchBase database served as the permanent data repository and was updated routinely. Data were exported into Microsoft Access (Microsoft Corp, Redmond, WA) for descriptive analyses. Inferential statistical analyses were performed by using SPSS (SPSS, Inc, Chicago, IL) and Stata (Stata Corp, College Station, TX).
Stepwise clustered logistic regression was used to explore the predictors of pharmacologic analgesia after surgery. The following variables were considered: extent of surgery (major or minor), pain assessments by physicians or nurse practitioners, pain assessment by the bedside nurse, whether the patient's attending physician was a neonatologist or not, the neonate's gender, gestational age, postnatal age, birth weight, length of stay in days, and number of postsurgical procedures. Models were clustered on hospital site to account for variable hospital pain management policies and physician characteristics within hospitals. Predictor variables with a P
.2 were retained in a final model. Analysis was performed by using the Stata command SW Logistic with the Cluster option.
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RESULTS
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Data from 250 patients were collected for this study on the basis of inclusion and exclusion criteria. Enrolled neonates had a birth weight of 2.4 ± 1.0 kg (mean ± SD; range: 0.55.3 kg); gestational age at birth of 36 ± 4.3 weeks (range: 2342 weeks), at surgery of 38 ± 4.5 weeks (range: 2860 weeks), age at NICU admission of 13.3 ± 28.2 days (range: 0157 days); and length of hospital stay of 23.5 ± 30.0 days (range: 1264 days). Most neonates (96% [n = 214]) were discharged alive from the hospital, were male (57% [n = 142]), and were born preterm (
37 weeks' gestation at birth; 54% [n = 136]).
Pain-Assessment Practices
Proposed standards of pain assessment require routine evaluations every 4 to 6 hours with the vital signs.9,10 Policies of the participating hospitals ranged from pain assessments every 4 hours to every 12 hours or once per nursing shift. Participating hospital policies regarding the use of numeric pain scales also varied widely. The 10 participating hospitals used 7 different tools to assess pain in neonates for the 72-hour postoperative study period (see Table 1). Two hospitals used a nonnumeric assessment tool, and 4 hospitals used >1 tool for different patient populations or clinical indications. The bedside nurse documented numeric pain-assessment scores for 88% of the patients (Table 2), and physicians or neonatal nurse practitioners (NNPs) documented numeric pain-assessment scores for 9% of the patients. There was no evidence of a numeric or nonnumeric pain assessment by physicians or NNPs for 64% patients.
Postoperative Pain Management
Documentation of pharmacologic therapy for postsurgical pain during the 72-hour study period was variable (Table 3). After major surgery, most (84%) neonates received opioid analgesia, 35% received nonopioid analgesics, 24% received benzodiazepines, and 63% received >1 class of agent. After minor surgery, 60% of the patients received opioids, 60% received nonopioids, 11% received benzodiazepines, and 83% received >1 class of agent. A small proportion (7% of major surgery patients and 12% of minor surgery patients) received no postoperative analgesia.
Nonpharmacologic interventions that typically are used for management of pain or discomfort were documented infrequently. Positioning was used in 32%, nonnutritive sucking was used in 15%, swaddling was used in 8%, and other behavioral interventions were used in 40% (eg, rocking, therapeutic touch, decreased stimulation, soothing sounds). Sucrose use for postoperative analgesia was noted for only 1% of patients who underwent minor surgery. One or more of these interventions were used for 127 (51%) patients.
Painful Postoperative Procedures
Almost all (96%) of the infants underwent acute painful procedures during the 72-hour postsurgical period. Most infants who underwent major or minor surgery also received endotracheal suctioning and heel sticks postoperatively (Table 4). Approximately one third had dressing changes and peripheral intravenous needle sticks. Infants who underwent major surgery received on average 18.2 ± 1.0 painful procedures postoperatively, whereas infants who underwent minor surgery received on average 14.2 ± 1.4 painful procedures. Infants who underwent major surgery were more likely to receive percutaneous central venous line insertion (P = .0004) or tracheal intubation (P = .07) after surgery.
Predictors of Postoperative Analgesia
Clinical factors that predicted the use of any pharmacologic pain management in the 72 hours after surgery were assessed in a logistic-regression model (Table 5). In bivariate analyses, only 3 factors of those considered played a significant role: major surgery (P = .043), physician/NNP pain assessment (P = .061), and age of the patient (P = .094). After sequential backward elimination of nonsignificant factors, only physician pain assessment (odds ratio [OR]: 4.04; 95% confidence interval: 1.2912.63; P = .01) remained as a significant predictor of analgesic use; major surgery (OR: 1.91; P = .18) and the patient's age (OR: 1.01; P = .16) did not seem to contribute. Physician pain assessment was documented for only 23 patients, and 22 of these received some type of postoperative analgesia.
ADEs
The documented incidence of ADEs that were associated with administration of postoperative pain medications was extremely low (2 [0.8%] of 250 patients). Both events involved hypoxia and respiratory depression after the administration of opioid analgesics (1 morphine, 1 fentanyl). Both patients required administration of Naloxone, and no lasting untoward effects were noted.
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DISCUSSION
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This study documents analgesic practices after surgery at 10 hospitals that participated in a collaborative practice improvement project. These findings are unique because they represent actual practice rather than the opinions of professional staff at various NICUs, and they focus only on the care of neonates for the first 72 hours after surgery. Other studies have focused on the incidence of acute pain that is associated with invasive procedures, mostly in nonsurgical neonates, with data from single institutions.3,8,1214 We found numerous inconsistencies in the assessment and management of postoperative pain in the NICU: (1) hospital standards were inconsistent with national standards for frequency of pain assessment; (2) hospitals used a variety of tools to assess neonatal pain, and the resulting pain assessments often were poorly documented; (3) additional painful procedures were common and would require interventions to alleviate pain; (4) nonpharmacologic interventions were not used in many NICUs; and (5) pharmacologic management for postsurgical analgesia was variable. The fragile medical condition of these patients, their inability to communicate postsurgical pain to caregivers, and evidence for the long-term effects of unrelieved pain make these findings especially troubling.1517
These observations, from the first cycle of a 2-cycle collaborative improvement project focused on postsurgical infants in the NICU, confirmed the extreme variability in postoperative pain management,1822 perhaps on the basis of inadequate or inaccurate assessments.5,2327 Given these findings, the participating hospitals immediately initiated the second cycle for improving the assessment and management of postoperative pain in the specific areas identified at each site.
A prerequisite for adequate pain management is the routine assessment of pain in neonates. Our data show that NICU bedside nurses consistently use objective pain-assessment tools, whereas those with prescriptive authority (physicians, NNPs) do not. This variability among professionals reveals, to a significant extent, the reluctance to use analgesic drug therapy for neonates,6,8,28 lack of communication between bedside nurses and physicians, or inconsistent use of numeric pain ratings to inform practice. It is remarkable that even nonpharmacologic interventions were used infrequently. Nonpharmacologic interventions are effective against procedural pain, are relatively inexpensive compared with analgesic drugs, and have minimal adverse effects; however, their efficacy for postoperative pain in neonates has not been explored adequately.
Many numeric pain assessment tools that are used for neonates have limited applicability for postoperative pain, whereas others are cumbersome for clinical use. The Premature Infant Pain Profile29 and CRIES scale30 were validated recently for postsurgical pain in neonates,5 but these tools were used by only 2 of the participating hospitals. Two other hospital sites adopted the use of Neonatal Pain, Agitation and Sedation Scale31 because of its face validity, ease of use, and unpublished preliminary pilot data, whereas other sites preferred to wait for published validity and reliability data.
The most significant finding of this study was that physicians and NNPs rarely documented pain assessments with numeric scores or even nonnumeric descriptors. Physicians or NNPs may be unfamiliar with the metric properties of numeric scales and/or unable to commit the time to use these tools in a busy NICU setting.32 Bedside nurses usually assess their patients for postoperative pain and then obtain therapeutic orders from physicians or NNPs, thereby reducing the need for a physician or an NNP to document numeric pain scales.
Despite the variability of pharmacologic analgesia in this population, it was most disconcerting that in the 72-hour period after a major surgical procedure, 16% of patients received no opioid analgesia and 7% received no analgesia at all. Previous reports of respiratory depression33,34 maintain the "opiophobia" for pain management in postoperative neonates, despite a deeper understanding of neonatal opioid pharmacology and a lower incidence of serious ADEs. Morphine and fentanyl remain the most commonly used analgesics for major surgery, and acetaminophen was used most commonly after minor surgery. Very few patients in our study received sedative medications, which can mask the pain response without relieving pain. The use of oral sucrose, which has analgesic effects in the neonate, was virtually absent, perhaps because the efficacy of sucrose for postsurgical pain has not been investigated.35
A logistic-regression model, designed to examine the role of various clinical factors that lead to the use of postoperative analgesia, showed that the odds of a neonate's receiving postoperative analgesia were 4 times higher when a physician had performed (and documented) a pain assessment than the neonates who were not assessed by a physician. It is intriguing that nursing pain assessments alone did not play a role in the decision to use analgesia, despite the voluminous literature on nursing pain assessments and increasing awareness of neonatal pain among NICU nurses.5,21,22,3638 In contrast, almost no information has been published in the pediatric surgical literature to promote the use of pain assessments in postsurgical neonates.
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LIMITATIONS
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The findings of this retrospective study are limited by reliance on the clinical data that were documented in the patient chart and by measurement of pain assessment and management at any time during the postoperative period. Medical charts often are considered incomplete for research purposes. Nonetheless, it is difficult to discount the absence of information on pharmacologic orders in the patient's medical chart. For many years, regulatory agencies have used medical chart documentation as the gold standard for deciding whether interventions were performed according to hospital policies. All of the participating children's hospitals were affiliated with academic institutions, and multiple entries in the chart normally document the use of a therapy, if it occurs. Conversely, the lack of documentation suggests that analgesic drugs or nonpharmacologic interventions were not used for neonates whose medical charts revealed no evidence of postoperative pain management.
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CONCLUSIONS
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Numerous deficiencies in the assessment and management of postoperative pain in neonates were identified in this study. Improvements and evidence-based guidelines for postoperative care clearly are needed for all providers of neonatal care. These improvements should be aimed at the education of professional staff; the systematic assessment of pain; validation of objective pain-assessment methods; randomized, controlled trials that compare pharmacologic or nonpharmacologic interventions (or combination therapy); and basic data on the safety and the efficacy of various therapies. The Newborn Drug Development Initiative mandated by the Best Pharmaceuticals for Children Act of 2003 has updated the approaches for assessment and management of neonatal pain that is associated with invasive procedures, surgical operations, or mechanical ventilation.11,3941 Findings from this study strongly reinforce the need for greater research in the area of postoperative pain.14 Clinical trial design must focus on preventing or managing postoperative pain as well as the pain that is associated with ongoing painful procedures in the postoperative period. These data provide the incentives and background for initiating significant changes in the practice of postoperative analgesia for neonates, thereby guiding the field toward evidenced-based practice for unique clinical settings.
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ACKNOWLEDGMENTS
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This project was supported by the CHCA and in part by grants from the Agency for Healthcare Research and Quality (1 U18 HS13698) and the National Institutes of Health (U10 HD50009 to Dr Anand and 1P20 RR018765 to E. Garcia-Rill, Principal Investigator).
We extend our thanks to the following members of the Child Health Accountability Initiative, who contributed to the development of the data-collection method, collected data, and assisted in review of the study results: Sandra McDougal, RN, MSN, and Barbara Kuppel, BSN, RN (Children's Hospital of Buffalo), Debbie Hershberger, RN, MSN, and Dawn Butler, PharmD (Cincinnati Children's Medical Center), Cindy Guess and Tammy Hoff, BSN (Cook Children's Medical Center), T.J. Green, MNSc (Arkansas Children's Hospital), Wilbert Mason, MD, MPH, and Deborah Jury, MSN, CPNP, CNS (Childrens Hospital Los Angeles), Steven Weisman, MD, and Antonella Ferrise, BSN, RN (Children's Hospital of Wisconsin), Beverly Walti, RN, MSN, CPNP, and Susan Feidner, RN (Children's Hospital of Orange County), Paul Sharek, MD, MPH, and Deirdre McAllister, RN (Lucile Packard Children's Hospital), Ann Spence, RN, and Teresa Mingrone, RN (Children's Hospital of Pittsburgh), and Susan Senecal, RN, MSN, and Gene Martin, RN, MS (All Children's Hospital). We extend special thanks to Steven Weisman, MD, and CHCA staff, including Virginia Morse, Cheri Throop, and Donna Payne.
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FOOTNOTES
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Accepted Apr 20, 2006.
Address correspondence to Kanwaljeet J.S. Anand, MBBS, DPhil, Arkansas Children's Hospital, Slot 900, 800 Marshall St, Little Rock, AR 72202. E-mail: anandsunny{at}uams.edu
The authors have indicated they have no financial relationships relevant to this article to disclose.
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