Zolpidem and sleep in pediatric burn patients with attention deficit/hyperactivity disorder.
With an estimated prevalence of 3% to 7% in school-aged children (National Center on Birth Defects and Developmental Disabilities [NCBDDD], 2011), attention deficit/hyperactivity disorder (ADHD) is considered the most commonly diagnosed neurobehavioral condition in children (American Academy of Pediatrics [AAP], 2011). The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) lists a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development as requirements for the diagnosis of ADHD (American Psychiatric Association, 2013). These behavioral characteristics increase a child's risk for accidental or intentional injury (Magnus, Bergman, Zieger, & Coleman, 2004; Shilon, Poliak, Aran, Shaked & Gross-Tsur, 2011). One type of injury common to children with ADHD are burn injuries because studies have characterized a pattern of patients with a diagnosis of ADHD as having experimented with fire (Badger, Anderson, & Kagan, 2008). Additionally, others have noted that children with ADHD were frequently involved in risk-taking behaviors at the time of burn injury (Badger, Anderson, & Kagan, 2008; Thomas, Ayoub, Rosenberg, Robert, & Meyer, 2004).When hospitalized due to burn injury, sleep, while at a premium for optimal convalescence, is not easily achieved. Studies have shown noise, lights, medical interventions, pain, positioning requirements, and anxiety to be a few examples of disruptors of quality sleep (Gottschlich et al., 1994; Honkus, 2003; Newson, 2007; Temboa & Parkerb, 2009). Existing research has also demonstrated a correlation between sleep deprivation and a decline in cognitive and emotional function (Honkus, 2003), pain tolerance, respiratory status (Temboa & Parkerb, 2009), immune function (Honkus, 2003; Temboa & Parkerb, 2009), and wound healing (Gottschlich, Khoury, Warden, & Kagan, 2009), all of which are paramount in burn recovery. This dyssomnia is further complicated in children with a pre-existing diagnosis of ADHD. The prevalence of sleep disruption in these patients is so profound that the DSM previously included restless and disturbed sleep as criteria for this diagnosis (Choi, Yoon, Kim, Chung, & Yoo, 2010; Gau & Chiang, 2009; Owens, 2005, 2009). Specifically, studies show children with ADHD have difficulties initiating and maintaining sleep (Brown & McMullen, 2001; Choi et al, 2010; Crabtree, Ivanevko, & Gozal, 2003; Hoban, 2004; Owens, 2005; Sung, Hiscock, Sciberras, & Efron, 2008).
Traditional methods to facilitate sleep include environmental changes (such as reduction in noise and light disturbance), coordinating care, and pain management--techniques that represent several interventions that can assist the acutely burned patient in achieving quality sleep. When these methods are insufficient, institutions may use sleep medications to promote sleep.
Zolpidem (Ambien[R]) is one such medication. Zolpidem is a sedative/hypnotic medication that slows brain activity allowing the initiation of sleep. It is recommended that zolpidem be taken for short periods of time because tolerance has been noted following two weeks of use (U.S. National Library of Medicine [NLM], National Institute of Health [NIH], n.d.). Limited studies have been performed on the effectiveness of zolpidem on pediatric burn patients with ADHD. However, a study examining the effect of zolpidem in children with ADHD found no reduction in sleep latency to sleep onset. Additionally, an increase in side effects, including dizziness, hallucinations, and headaches, was noted compared to the control sample (Blumer, Fundling, Shih, Soubrane, & Reed, 2009). Burn patients spend markedly less time in the restorative stages of sleep, less than 7% as compared to 48% in the normal population. Additionally, a study of pediatric burn patients found zolpidem to minimally increase total and restorative sleep time (Armour, Khoury, Kagan, & Gottschlich, 2011).
The purpose of this study was to examine the effectiveness of zolpidem in hospitalized children with burn injuries by differentiating the sleep latency, time, and patterns in those with and without a pre-existing ADHD diagnosis.
Methods
A retrospective chart review was conducted of all children with acute burn injuries with a length of stay greater than three days admitted to Shriners Hospitals for Children in Cincinnati, Ohio, between the years 2005 and 2011 (N = 320). A review of each patient's diagnostic coding, nursing admission history, psychiatric consultation, as well as physician's notes, was performed to identify all patients with a pre-burn diagnosis of ADHD. These charts were examined to isolate those patients initially placed on zolpidem for sleep disturbances. The medical records of 205 children admitted for burn care were identified as being coded for ADHD; however, only 23 of these patients were initially placed on zolpidem for sleep, and therefore, were included in this study. These subjects were then matched for age, gender, percentage of total body surface area (TBSA) burn, extent (percentage) of third-degree burn, inhalation injury, and ventilator status to patients without a pre-burn diagnosis of ADHD.
Length of time on zolpidem and any changes in medication or dosing were analyzed within and between the two groups to determine the effectiveness of the medication. Tolerance has been reported when zolpidem is taken for two weeks or longer (NLM NIH, n.d.). Therefore, for the purpose of this study, effectiveness was defined as no need for a change in the sleep medication regimen during the first 12 days of treatment.
Comparisons between the paired patients with and without a history of ADHD were made by paired f-test and McNemar's test. Data were analyzed using Statistical Analysis Software version 9.1.3 (Raleigh, NC).
Results
Twenty-three subjects with a known history of ADHD prior to admission were matched to 23 patients without an ADHD diagnosis. Paired t-tests demonstrated no significant differences in age, percentage of full-thickness burn, and percentage of total body surface area burn. Additionally, gender, inhalation injury, and the need for mechanical ventilation during zolpidem dosing were found to be not significantly different using McNemar's tests (see Table 1).
A change in sleep medication regimen prior to day 12 was required in 69.6% of the patients with ADHD (n = 16) as compared to 56.5% of patients without ADHD (n = 13). This difference was not statistically different (p = 0.541). It is noteworthy, however, that patients with ADHD required a change in their sleep medication due to its ineffectiveness approximately 4 days earlier than those without ADHD (p = 0.06) (see Table 2).
Discussion
Although a pattern of ineffectiveness of zolpidem in both groups was noted in this study, statistical significance was not achieved, possibly due to small sample size. Additionally, the use of zolpidem as a first-line medication for sleep at our hospital began in 2005 limiting the number of patients available for inclusion prior to this date. ADHD is also frequently not diagnosed until school age, making it likely that younger patients might not have been included in this study due to the ADHD diagnosis being made after the acute burn admission. Further, it is also possible that the diagnosis of ADHD might not have been considered at the time of initial history and physical examination, thus contributing to the small sample size.
Our findings of zolpidem's ineffectiveness are consistent with those of Blumer et al. (2009) and Armour et al. (2011). In the study by Blumer et al. (2009), polysomnographic data was collected on children with ADHD related insomnia comparing zolpidem to a placebo; no improvement was noted in total sleep time, sleep efficiency, wake after sleep onset, or latency to persistent sleep. Armour et al. (2011) noted, via polysomnography, that wakefulness remained excessively high, 1214% of normal, in pediatric burn patients using zolpidem for sleep.
Treatment of sleep disturbances during burn injury hospitalization remains a challenge. This study suggests that sleep disorders are similar in pediatric burn patients with and without a concurrent diagnosis of ADHD. Further, zolpidem does not appear to promote sleep in either pediatric burn patient population. In view of the results of this study, it is clear that clinical assessment and monitoring of various pharmacologic, environmental, and behavioral sleep interventions is paramount. The importance of a nursing plan of care designed to minimize sleep deprivation, including coordination of care to decrease disruptions and awakenings, promoting pre-hospital bedtime rituals, and reducing lights and noise are measures that should be employed until future studies provide the much needed evidence-based guidelines for sleep optimization in burned children with and without ADHD.
Future Research Direction
Polysomnography (PSG) is considered the gold standard for measuring sleep (Gottschlich, Mayes, Khoury, Simakajornboon, & Kagan, 2013; Kushida et al., 2005; Temboa & Parkerb, 2009) because it provides the researcher a means of differentiating the stages of sleep. However, polysomnography is expensive and has been shown to cost approximately 16 man hours from data collection to data analysis (Armour et al., 2011), and it is one reason this test is not performed on every burn patient. Due to limitations and cost-effectiveness of polysomnography, this study used change in sleep medication as the marker for poor quality of sleep. Although hourly nursing assessment stating a patient's level of consciousness was available, studies have found this to be less than accurate (Armour et al., 2011; Temboa & Parkerb, 2009). Examination of polysomnographic data collected on patients with ADHD prior to and during use of zolpidem, as well as during use of any subsequent sleep medication, would provide objective data for accurately assessing quality and quantity of sleep.
Further examination of zolpidem's effectiveness in children with ADHD through a multi-institutional study would be of benefit; however, given this drug's minimal effectiveness in children and the expense of PSG testing, this is unlikely to occur. Finally, a randomized intervention trial would help determine what medication is best practice for promoting sleep in pediatric burn patients both with and without ADHD.
Acknowledgment: Funding for this study was provided by Shriners Hospitals for Children, Tampa, FL. This paper was presented at the 2012 Annual Meeting of the American Burn Association, Seattle WA and 2013 1st Annual TriState Nursing Excellence Symposium, Cincinnati, OH.
References
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Stephanie D. Cronin, MSN, RN, is an Emergency Staff RN, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
Michele M. Gottschlich, PhD, RD, is Director of Nutrition, Shriners Hospitals for Children--Cincinnati, Cincinnati, OH.
Lacy M. Gose, RN, is a Staff RN, Shriners Hospitals for Children--Cincinnati, Cincinnati, OH.
Richard J. Kagan, MD, was Chief of Staff, Shriners Hospitals for Children--Cincinnati, Cincinnati, OH, at the time this article was written.
Table 1.
Patient Demographics
ADD/ADHD Non-ADD/ADHD
(n = 23) (n = 23)
Age at burn (years) 11.0 [+ or -] 3.7 11.0 [+ or -] 3.6
Percentage total body 35.6 [+ or -] 19.5 34.7 [+ or -] 20.9
surface area
(TBSA) burn
Percentage third- 22.5 [+ or -] 18.2 23.6 [+ or -] 21.1
degree burn
Gender (female) 3 (13.04) 3 (13.04)
Inhalation injury 1 (4.35) 1 (4.35)
Ventilator 10 (43.5) 9 (39.1)
p-Value
Age at burn (years) 0.77
Percentage total body 0.75
surface area
(TBSA) burn
Percentage third- 0.8
degree burn
Gender (female) 1
Inhalation injury 1
Ventilator 1
(Mean [+ or -] SD or n [%])
Notes: ADD = attention deficit disorder;
ADHD = attention deficit/hyperactivity disorder.
Table 2.
Comparison of Patients Requiring Sleep Medication Change
ADD/ADHD non-ADD/ADHD
(n = 23) (n = 23) p-Value
Number patients 16 (69.6%) 13 (56.5%) 0.54
requiring change
Median days 5 9 0.06
before change
Notes: ADD = attention deficit disorder;
ADHD--attention deficit/hyperactivity disorder.
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| Author: | Cronin, Stephanie D.; Gottschlich, Michele M.; Gose, Lacy M.; Kagan, Richard J. |
|---|---|
| Publication: | Pediatric Nursing |
| Article Type: | Report |
| Date: | May 1, 2015 |
| Words: | 2578 |
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