Abstract
Objective:
This study attempts to examine long-term pain medication usage after burn injury and its association with functional and psychosocial outcomes.
Design:
This is a multi-center retrospective cohort study utilizing the Burn Model System National Longitudinal Database. Participants injured from 2015 to 2021 were divided into two groups, those taking and not taking prescription pain medication at 12 months after injury. Regression analyses examined associations between pain medication use and outcomes at 12 months, adjusting for demographics, burn size, length of hospital stay, and pre-injury pain medication use and employment status. Outcomes included VR-12 Physical and Mental Component Summary scores (PCS and MCS), Patient-Reported Outcomes Measurement Information System (PROMIS-29) Anxiety and Depression scores, Satisfaction with Life Scale (SWLS), and employment status.
Results:
Of 358 participants analyzed, prescription pain medication use was associated with worse outcomes at 12 months: PCS (β=−7.11, p<0.001), MCS (β=−6.01, p<0.001), and PROMIS-29 Depression (β=4.88, p<0.001) and Anxiety (β=6.16, p<0.001). SWLS was not significantly associated with pain medication use (p=0.069) and those taking pain medication were 52% less likely to be employed at 12 months (p=0.035).
Conclusion:
There is a significant association between prescription pain medication use and worse physical, mental, and employment outcomes at 12 months after burn injury.
Keywords: Burns, pain, medication, outcomes
Introduction
Prescription pain medications are commonly used to manage pain after burn injury. For over a century, opioids have been used to treat moderate to severe pain.1 Over the past three decades, increasing findings of consequences related to opioid misuse led to the Centers for Disease Control and Prevention (CDC) declaration of a United States (US) public health emergency.2 While opioids are an important agent in the management of pain after burn injury, the adjunct use of nonopioid medications to treat chronic pain has continued to evolve.3 Medications such as gabapentin, tricyclic antidepressants, and others are commonly used in chronic pain, but there is limited data examining their use and efficacy in the burn patient population.4 One study found a non-significant difference in long-term functional outcomes with the initial use of gabapentin to treat neuropathic pain after burn injury.5 Little is known about long-term prescription pain medication use and its association with health-related quality of life outcomes in this population.
According to the Drug Enforcement Administration (DEA), approximately 13% of all US prescriptions are for controlled substances.6 At its height in 2012, more than 255 million opioid prescriptions were written in the US.7 However, it is unclear how often pain medication is prescribed at discharge across all pain management cohorts due to a lack of centralized repositories for general healthcare and clinical research. In response, the National Institute of Health (NIH) has recently advocated for increased research on pain management, overdose reversal, and addiction treatment.8
Guidelines for prescribing opioid pain medications for burn injuries were developed sixteen years ago by the American Burn Association (ABA) and were recently updated in 2020. Strong to moderate recommendations were given for repeated and protocolized assessments of pain during hospitalization, as well as moderate to weak evidence for individualization and weaning of opioids and continued consideration of nonopioid pain medications in multimodal regimens.9 However, most studies examining the use of prescription pain medication, opioid or nonopioid, focus on the acute setting and do not study the potential relationship of chronic prescription pain medication on patient outcomes.10
Gaining a more comprehensive understanding of prescription pain medication use among people living with burn injury and its relationship with long-term outcomes may help clinicians develop more tailored screening and treatment strategies to minimize pain medication misuse and maximize recovery. The purpose of this study was to assess patterns of prescription pain medication use after burn injury and their association with functional and psychosocial outcomes. The authors hypothesize that continued use of prescription pain medication use in patients living with burn injury is associated with worse functional and psychosocial outcomes at 12-month follow-up.
Methods
Database and Study Population
This is a multi-center retrospective cohort study utilizing the Burn Model System (BMS) National Longitudinal Database. This database is funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) and was established in 1993 to examine the functional and psychosocial outcomes of people living with burn injury. This study was approved by the Mass General Brigham Institutional Review Board (#2011P001264) as part of the overarching BMS program. The BMS has been shown to be representative of severely burned individuals in the US.11 BMS National Longitudinal Database inclusion criteria consist of requiring a surgery for wound closure and meeting one or more of the following criteria: 18–64 years of age with a burn injury ≥20% total body surface area (TBSA) burned, or ≥65 years of age with a burn injury ≥10% TBSA burned, or any age with a burn injury to their face/neck, hands, or feet, or any age with a high-voltage electrical or lightening burn injury. Participating patients underwent a written informed consent prior to enrollment in the database. Details of the BMS National Longitudinal Database inclusion criteria, data collection process, and data collection sites can be found at http://burndata.washington.edu/.12 This study conforms to all STROBE guidelines and reports the required information accordingly (see Supplementary Checklist, http://links.lww.com/PHM/C310). The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
For this study, adults (at least 18 years at time of injury) in the BMS National Longitudinal Database enrolled between August 2015 and July 2021 who answered the pain medication use question at discharge and 12-month follow-up were included. The sample was divided into two groups for analysis, those taking and not taking prescription pain medications (inclusive of opioids and non-opioid pain medication as described below) at 12-months after injury.
Demographic and Clinical Variables
Demographic and clinical variables were collected from medical records and surveys at discharge and included age, sex, race, ethnicity, marital status, pre-injury pain prescription use, burn etiology, burn size (% TBSA), and length of hospital stay. Self-reported clinical variables included CAGE Drug and Alcohol Abuse. The CAGE Drug and Alcohol Abuse screens potential drug and/or alcohol misuse using a 4-item questionnaire with binary yes/no response options. Affirmative answer to any two of the items constituted a positive CAGE screen.13
Variables related to prescription pain medication use were assessed at pre-injury (recall at discharge), discharge (medical record abstraction) and follow-up (self-report at 12-month follow-up). Type of prescription pain medication was only available at discharge and was categorized into three groups: opioid pain medication (e.g., methadone, codeine, hydrocodone, oxycodone, hydromorphone, fentanyl, morphine, and acetaminophen with codeine), neuropathic pain medication (e.g., gabapentin and amitriptyline) and unknown. At discharge, patients were asked to recall their prescription pain medication use through the following question: “Did you take any pain medications on a regular basis for pain during the month before your burn injury?” At 12-month follow-up, the following pain medication question was asked: “In the past month did you take prescription medication for pain on a regular basis?” Both questions were coded as a binary yes/no response.
Outcome Measures
Functional and psychosocial outcomes were self-reported by participants at 12-month follow-up. The primary outcome was VR-12 Physical and Mental Component Summary (PCS and MCS) scores. Secondary outcomes included the Patient-Reported Outcomes Measurement Information System (PROMIS-29) Depression and Anxiety domain scores, Satisfaction with Life Scale (SWLS) scores, and employment status at 12 months. The following is a detailed description of each of the outcomes used to assess long-term functional and psychosocial outcomes:
VR-12 PCS and MCS:
The VR-12 instrument is composed of two summary scores: the PCS and MCS score. PCS assesses physical outcomes while MCS assesses emotional outcomes, as well as mental health outcomes associated with physical functioning and role limitations.11 PCS and MCS are standardized assessments using a T-score transformation with a mean of 50 and standard deviation of 10, normalized to a national US population. Higher scores denote better health. Differences of 0.2 of 1 SD or two points are considered small, 0.5 of 1 SD or five points are moderate and 0.8 of 1 SD or eight points or greater are large effect sizes.14,15
PROMIS-29 Depression and Anxiety:
The PROMIS-29 Depression (6 items) and Anxiety (6 items) use 5-point Likert subscales to assess the respective domains. The summed score for each subscale is converted to a standardized T-score with a mean of 50 and standard deviation of 10. A lower score presents better symptom on the domain. The PROMIS-29 subscales have demonstrated good reliability and validity in the adult burn population.16
SWLS:
The SWLS is a validated 5-item scale that measures life satisfaction. Response options range from 1 “strongly disagree” to 7 “strongly agree” with a maximum score of 35; a score of 20 indicates the neutral point of satisfaction and dissatisfaction; higher scores indicate greater satisfaction with life. It has established reliability and has been validated in the adult burn injury population.17
Employment Status:
Employment status was self-reported at follow-up. Patients responded to the following question: “What is your current employment status?”. Those who responded as working full or part-time were considered employed, with other answers (retired, not working, homemaker/caregiver) considered not employed.
Analysis
Descriptive statistics were examined. Data are presented as mean (standard deviation) for continuous variables and frequency (percentage) for categorical variables. A comparison between groups using independent t-test or Mann-Whitney U test for continuous variables and Chi-square test for categorical variables was done for baseline clinical variables. Ordinary least squares regression analyses for continuous outcome variables (VR-12 PCS and MCS, PROMIS-29 Depression and Anxiety, and SWLS) and logistical regression analysis for binary outcome variable (employment status) were performed to examine the association between pain medication use and outcomes at 12-month. All regression analyses were adjusted for age, sex, race, ethnicity, pre-injury employment status, pre-injury pain prescription use, burn size, and length of hospital stay. Robust variance estimators were used to account for heteroskedasticity in all models. Each regression utilized available outcome data without imputation, and less than 9% of missing data was noted for each regression.
Results
Cohort description
A total of 358 BMS participants were included in this study, with 105 individuals in the pain medication use group and 253 individuals in the no pain medication use group. Mean age was 48.8 years in the pain medication use group and 45.8 years in the no pain medication use group. Approximately a half of participants in the two groups (46% vs 50%) were married or lived with a partner. The majority of participants were male (66% vs 70%), and White (non-Hispanic) (68% vs 65%) with fire or flame burn injuries (63% vs 57%). Differences in demographic and clinical variables between the two groups (prescription pain medication use vs non-use at 12 months) include pre-injury pain medication use (25% vs 7%, p<0.001), TBSA burned (27% vs 16%, p<0.001) and length of hospital stay (45.0 vs 24.5 days, p<0.001). Refer to Table 1 for detailed demographic data.
Table 1:
Demographic and Clinical Characteristics
| Pain Medication Use at 12-month (n=105) | No Pain Medication Use at 12-month (n=253) | p value | |
|---|---|---|---|
|
| |||
| Age at injury, mean (SD) | 48.8 (14.8) | 45.8 (16.7) | 0.067a |
| Male sex, n (%) | 69 (65.7%) | 178 (70.4%) | 0.387b |
| Race/Ethnicity, n (%) | 0.286b | ||
| White (non-Hispanic) | 71 (68.3%) | 163 (65.2%) | |
| Black (non-Hispanic) | 11 (10.6%) | 16 (6.4%) | |
| Hispanic | 19 (18.3%) | 56 (22.4%) | |
| Other | 3 (2.9%) | 15 (6.0%) | |
| Married/Living with a partner, n (%) | 47 (45.6%) | 125 (49.8%) | 0.476b |
| Pre-Injury pain medication use, n (%) | 26 (24.8%) | 18 (7.1%) | <0.001c |
| Pain medication use at discharge, n (%) |
83 (79.1%) |
195 (77.1%) |
0.245b |
| Burn etiology, n (%) | 0.784b | ||
| Fire/Flame | 66 (62.9%) | 145 (57.3%) | |
| Scald | 10 (9.5%) | 30 (11.9%) | |
| Electric | 6 (5.7%) | 18 (7.1%) | |
| Otherc | 23 (21.9%) | 60 (23.7%) | |
| TBSA, mean (SD) | 26.50 (22.8) | 15.97 (17.8) | <0.001a |
| Length of hospital stay, mean (SD) | 45.00 (44.5) | 24.50 (32.2) | <0.001a |
| (at discharge) | |||
| CAGE Drug Abuse (yes), n (%) | 7 (6.8%) | 10 (4.1%) | 0.276b |
| CAGE Alcohol Abuse (yes), n (%) | 16 (15.5%) | 29 (11.6%) | 0.314b |
Note. This table presents demographic and clinical characteristics for burn survivors with using pain medication and those without using pain medication at 12-month follow-up. T-test for continuous variables (age at injury, TBSA, and length of hospital stay) and Chi-square test for categorical variables (sex, race/ethnicity, marital status, pre-injury pain medication use, pain medication use at discharge, burn etiology, and CAGE Drug/Alcohol Abuse,) were used to examine differences between the two groups.
SD: Standard Deviation; TBSA: Total Body Surface Area.
Mann Whitney U test;
Chi-square test
Independent t test. The p<0.05 indicates a statistically significant difference.
Other etiologies include contact with hot object, grease, tar, chemical, flash burns, and other unknown etiologies.
Of the total 358 participants, 12.3% reported prescription pain medication use prior to their injury. At discharge, 77.7% of individuals reported prescription pain medication use and 18.2% were unknown. Of those who reported pain medication use at discharge, 93.2% of these patients were discharged with at least one opioid medication. At 12 months, 29.3% of individuals indicated prescription pain medication use. Refer to Figure 1 for detailed prescription pain medication reporting at discharge.
Figure 1. Types of Prescription Pain Medication Use at Discharge for the Two Groups.
This figure provides a breakdown of type of pain medication use at discharge. This breakdown is separated into the two groups used for analysis: those who reported taking or not taking pain medication at 12-months after injury. For those taking pain medication at 12 months, 21.0% used opioid pain medication only, 6.7% used neuropathic pain medication only, and 51.4% combinedly used opioid and neuropathic pain medication, with 1.9% non-use pain medication and 19.0% unknown at discharge. For those not taking pain medication at 12 months, 43.1% used opioid pain medication only, 4.7% used neuropathic pain medication only, and 29.2% combinedly used opioid and neuropathic pain medication, with 5.1% non-use pain medication and 17.8% unknown at discharge.
Primary Outcomes
Regression analyses demonstrated that prescription pain medication use at 12 months was significantly associated with lower (worse) PCS (β = −7.11; 95% CI = −9.68, −4.54; p < 0.001) and MCS scores (β = −6.01; 95% CI = −9.16, −2.86; p < 0.001) at 12 months. After adjusting for covariables, on average, those who used prescription pain medications at 12-month had lower PCS scores by 7.11 points and MCS scores by 6.01 points compared to those who did not, reflecting a moderate effect size for both outcomes. Although PCS and MCS score minimal clinically important differences in the burn population have not been examined, these results are greater than approximate estimates of meaningful change defined as 0.5 standard deviations from population norms (VR-12 0.5 SD = 5).18,19 For comparison, studies have reported differences of > 3.29 in PCS and > 3.77 in MCS scores as significant in the chronic low back pain population.20
Secondary Outcomes
Similarly, regression analyses demonstrated pain medication use at 12 months was significantly associated with higher (worse) PROMIS-29 Depression (β = 4.88; 95% CI = 2.47, 7.28; p < 0.001) and Anxiety scores (β = 6.16; 95% CI = 3.88, 8.45; p < 0.001). Similarly, these scores approach approximate estimates of meaningful change as previously described (PROMIS-29 0.5 SD = 5).19 SWLS score was not significantly associated with prescription pain medication use at 12-month (β = −1.98; 95% CI = −4.12, 0.15; p = 0.069). Additionally, those who used prescription pain medication were 52% less likely to be employed when compared to those who did not report prescription pain medication use (OR = 0.48; 95% CI = 0.25, 0.95; p = 0.035). Refer to Table 2 for detailed outcome measure scores and Table 3 and 4 for regression analysis results as described above.
Table 2:
12-Month Outcome Measures
| Pain Medication Use at 12-month (n=105) | No Pain Medication Use at 12-month (n=253) | |
|---|---|---|
|
| ||
| VR-12 PCS, mean (SD) | 37.4 (10.4) | 47.8 (10.7) |
| VR-12 MCS, mean (SD) | 46.6 (14.0) | 53.4 (11.0) |
| PROMIS-29 Depression | 52.7 (1.1) | 46.9 (0.5) |
| PROMIS-29 Anxiety | 53.5 (1.0) | 47.2 (0.6) |
| SWLS, mean (SD) | 20.4 (8.7) | 24.4 (8.5) |
| Employment Status (yes), n (%) | 33 (34.4) | 143 (57.4) |
Note. This table presents outcome results for burn survivors with using pain medication and those without using pain medication at 12-month follow-up.
PROMIS-29: Patient-Reported Outcomes Measurement Information System; SD: Standard Deviation; SWLS: Satisfaction with Life Scale; VR-12 MCS: Veterans RAND 12-Item Health Survey Mental Component Summary; VR-12 PCS: Veterans RAND 12-Item Health Survey Physical Component Summary.
Table 3:
Linear Regression Analyses of Pain Medication Use and Outcomes at 12 Month Follow-up
| n | Coefficient | 95% CI | SE | p value | |
|---|---|---|---|---|---|
|
| |||||
| VR-12 PCS | 327 | −7.11 | −9.68, −4.54 | 1.30 | <0.001 |
| VR-12 MCS | 327 | −6.01 | −9.16, −2.86 | 1.60 | <0.001 |
| PROMIS-29 Depression | 340 | 4.88 | 2.47, 7.28 | 1.22 | <0.001 |
| PROMIS-29 Anxiety | 340 | 6.16 | 3.88, 8.45 | 1.16 | <0.001 |
| SWLS | 332 | −1.98 | −4.12, 0.15 | 1.09 | 0.069 |
Note. This table presents ordinary least squares regression analyses examining the association between outcome results and prescription pain medication use at 12-month follow-up, controlling for age, sex, combined race and ethnicity, TBSA, hospital stay length and pre-injury prescription pain medication use. Each row in the table relays the association between pain medication use at 12-months and the outcome listed based on separate regression analyses.
CI: Confidence Interval; PROMIS-29: Patient-Reported Outcomes Measurement Information System; SE: Standard Error; SWLS: Satisfaction with Life Scale; VR-12 MCS: Veterans RAND 12-Item Health Survey Mental Component Summary; VR-12 PCS: Veterans RAND 12-Item Health Survey Physical Component Summary.
The p<0.05 indicates a statistically significant difference.
Table 4:
Logistical Regression Analyses of Prescription Pain Medication Use and Binary Outcome Results at 12-Month Follow-up
| n | OR | 95% CI | SE | p value | |
|---|---|---|---|---|---|
|
| |||||
| Employment Status | 330 | 0.48 | 0.25, 0.95 | 0.48 | 0.035 |
Note. This table presents results of a logistic regression analysis examining the association between employment and prescription pain medication use at 12-month follow-up, controlling for age, sex, combined race and ethnicity, TBSA, hospital stay length, pre-injury employment and pre-injury prescription pain medication use.
CI: Confidence Interval; OR: Odds Ratio; SE: Standard Error.
The p<0.05 indicates a statistically significant difference.
Discussion
In this study, there are significant associations between prescription pain medication use and worse functional and psychosocial outcomes at 12 months. Although these associations are not causal and we were not able to estimate the effects of opioids or other prescription pain medications specifically, these findings allow meaningful conclusions to be drawn about the important associations between any pain medication and lower health-related quality of life long after burn injury. Further, these findings could catalyze development of a more rigorous framework for prescribing, weaning, and/or monitoring long-term medications for pain management after burn injury. These results add to the existing literature on prescription pain medication use in other rehabilitation populations such as spinal cord injury (SCI), traumatic brain injury (TBI), and multiple traumas, with many finding increased risks of poor chronic functional outcomes.21–23 One study noted a quarter of patients with major physical trauma continued to use prescription pain medication 1 year from surgery, and another study correlated continued use with significant worsened functional outcomes and lower return to work rates.24,25
PCS & MCS
This study showed that prescription pain medication use was associated with worse PCS and MCS scores at 12 months. Although this study establishes an association between pain prescription use and worse functional outcomes, there are multiple factors that could explain this difference in functional outcomes. Clinicians should consider factors such as side-effects related to prescription pain medication usage, the functional sequelae of chronic pain on a patient’s physical or mental function, or the presence of undertreated chronic pain. Although these relationships are not well-studied in the burn population, other patient populations with chronic pain have demonstrated decreased physical and psychosocial function as a consequence of chronic medication or chronic pain.26,27 Additionally, these findings might be explained, in part, by differences in health systems with regard to medication prescription patterns, screening protocols, monitoring strategies, and use of non-pharmacological strategies. Together, these findings suggest the need to closely monitor and actively manage both acute and chronic pain and prescription pain medications following a burn injury and to consider addressing a likely multi-factorial etiology of pain (e.g., wounds, scar, co-incident stress syndromes, depression, anxiety, or financial toxicity).
Other Outcomes
Similar to MCS and PCS outcomes, the PROMIS-29 Anxiety and Depression results support the association between worse mental outcomes in patients who continued to use prescription pain medication at 12 months.16 However, the SWLS score, related to well-being of multiple social domains, showed a non-significant negative trend with long-term prescription pain medication use. This is consistent with a recent study reporting 60% of BMS participants having stable SWLS scores over two years.28 Factors of burn size, employment, school status, inhalation injury, and gender may play more significant roles in satisfaction with life than factors more directly related to pain medication use.28,29 In this study, participants were almost half as likely to be employed at 12 months if they reported continued use of prescription pain medication. Similar results have been reported in literature based on BMS data, which found pre-injury employment as a significant factor in employment at 12 months. It also reported that preinjury alcohol and drug misuse was not associated with employment status at 12 months.30 These findings contribute to existing literature of risk factors for unemployment for the working-age survivor of burn injury.
Limitations
There are several limitations of this study. Firstly, dosages and frequencies of prescription pain medications were not collected. While the type of pain medication was only collected at discharge, the lack of specific prescription information at pre-injury and 12-month limits the conclusions related to specific pain medication classes (i.e. opioid versus nonopioid). Due to the self-reported nature of key exposures and outcomes, there may be social response bias or missing data in reported prescription pain medication use. Baseline functional outcome scores were not included in this analysis due to the effect of recall bias (data was collected post-injury) and limited availability in the study sample. Each regression utilized available outcome data without imputation, and less than 9% of missing data was noted for each model. Additionally, while this study attempted to adjust regression models for known clinical factors that could influence prescription pain medication use (e.g., age, sex, injury severity, pre-injury pain medication use), it does not account for other potentially confounding factors such as concurrent psychiatric disorders that could influence outcomes and other factors that are not collected in the database. Regardless, these findings suggest that any prescription pain medication used over the long-term should be considered as a bellwether for potential lower health-related quality of life and the need for focused screening and targeted treatment strategies to bring these patients back to outcomes commensurate with their peers.
Finally, this study does not examine the rationale or reason for pain medication use at 12 months, and cannot establish a causal relationship between pain medication use and outcomes of interest. There are many potential reasons for taking prescription pain medication at 12 months. Continued prescription pain medication usage could be due to chronic pain, further surgical or reconstructive burn care, and other medical conditions not related to burn injury. These could potentially affect the results of this study. Further studies focused on outcomes related to pain intensity and rationale for chronic pain medication usage, which this study does not examine, could further clarify this relationship.
Conclusion
This study showed that patients with burn injuries taking prescription pain medication at one year had worse functional and psychosocial outcomes at 12-month follow-up compared with those who did not report taking them. Further understanding of prescription pain medication use and its association with long-term outcomes may aid clinicians in developing tailored screening, monitoring, and treatment plans for survivors to manage pain after burn injury
Supplementary Material
Summary.
What is Known:
Prescription pain medication usage is common after burn injury to manage acute and chronic pain. The use of opioid and non-opioid medications has been associated with mixed long-term functional and physical outcomes, and have not been examined in the burn population.
What is New:
The use of prescription pain medication in burn injury patients at 12 months is associated with worsened physical, mental, and employment outcomes.
Acknowledgements
This work was supported by the National Institute on Disability, Independent Living, and Rehabilitation Research (grant number: #90DPBU0001, #90DPBU0003, #90DPBU0004, #90DPBU0008). NIDILRR is a Center within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this presentation do not necessarily represent the policy of NIDILRR, ACL, HHS, and you should not assume endorsement by the Federal Government.
All authors have met criteria for authorship and have substantially contributed to contributing to the conception and design or analyzing and interpreting data and/or drafting the article or revising it critically for important intellectual content. No authors have any competing interests, financial benefits, or conflicts of interest to disclose. This work was supported by the National Institute on Disability, Independent Living, and Rehabilitation Research (grant number: #90DPBU0001, #90DPBU0003, #90DPBU0004, #90DPBU0008), with author Jeffrey Schneider, MD as a recipient. All other authors did not directly receive funding for the conduction of this study.
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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