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This study sought to characterize the nature of breakthrough pain experienced by 22 hospice patients and to assess the perceptions of their respective caregivers. Questionnaires were administered by trained hospice nurses to determine key elements of episodic pains in this home-based terminally ill population. Eighty-six percent of the patients surveyed experienced breakthrough pain, with an average of 2.9 episodes per 24-hr period and a mean pain intensity of 7 on a ten-point scale, compared with average baseline pain scores of 3.6 (daytime) and 2.6 (nighttime). Breakthrough pain episodes lasted 52 min on average, with a range of 1–240 min. The range of time to relief of breakthrough pains was 5–60 min, with a mean of 30 min. Caregivers’ perceptions of the pain intensities, duration, amount of relief, and time to relief were much more likely to be inaccurate, and were usually underestimates. This study suggests that breakthrough pain is common in the hospice setting and that there is poor concordance between patients’ self-reports and their caregivers’ perceptions of these pains. It is concluded that the pharmacodynamics of currently available oral analgesics are not well-suited for breakthrough pain and that better communication between patients and caregivers may lead to more optimal pain management.
Episodes of severe pain occurring on a background of otherwise controlled pain, known as breakthrough pain, is acknowledged as an important contributor to suffering in these patients.
evaluated inpatients in a major regional cancer referral center, documenting the common occurrence and characteristics of breakthrough pain. To supplement those observations, this survey was designed to evaluate the characteristics of these episodic pains occurring in home-based hospice patients. Because these patients are highly dependent upon a primary caregiver within the home, the perceptions of these caregivers were also viewed as relevant.
Methods
The study was approved by the University of Utah Institutional Review Board. A questionnaire was developed to collect salient data regarding breakthrough pain from interviews with hospice patients with a history of persistent pain. A similar questionnaire was worded to assess breakthrough pain information from the perspective of the patients’ primary caregivers. To accommodate the debilitated state of this patient population, questionnaires were designed by field test to be administered in under 15 min.
Home hospice nurses were trained in the use of the questionnaires and recorded patient and caregiver responses from a convenience sample of consecutive patients. Nurses were instructed to survey those patients under their care who they knew were experiencing some degree of pain due to their disease. Only patients who were able to communicate and who had a caregiver at home were included. Each patient/caregiver questionnaire was completed one time with attention drawn to the previous 24-hr period of time. Breakthrough pain was defined as “a transitory increase in pain to greater than moderate intensity (that is, to an intensity of `severe’ or `excruciating’) which occurred on a baseline pain of moderate intensity or less (that is, no pain or pain of `mild’ or `moderate’ intensity).”
In addition to basic demographics, the following variables were recorded:
1.
Current analgesics taken on a fixed schedule. Usual pain intensity during most hours of the day and night.
2.
Number of breakthrough pain episodes per 24-hr period.
3.
Usual average severity of breakthrough pain episodes.
4.
Usual duration of breakthrough pain episodes.
5.
Predictability and causes, if identifiable, of breakthrough pains.
6.
Quality of breakthrough pains (word descriptors from a proferred list).
7.
Body locations of breakthrough pains.
8.
Interventions for treating breakthrough pains.
9.
Amount of relief from breakthrough pain intervention(s).
10.
Time until meaningful relief from breakthrough pain.
11.
Anticipatory treatment (prevention) of breakthrough pain.
Pain intensity/severity and relief scores were assessed and reported using a 0–10 linear analogue scale. Means, modes, or both were derived for numerical data but statistical significance was not reported due to the small sample size.
Results
Demographics
Twenty-two home hospice patients, 9 males and 13 females, and their respective primary caregivers completed the survey. Four patients were between 8 and 18 years, eight patients were between 19 and 65 years, and ten patients were 65 years of age or older. Primary diagnoses included breast cancer (three patients), lung cancer (three patients), prostate cancer (two patients), leukemia (two patients), progressive neuromuscular disease (two patients), and one each of cancers originating in the brain, liver, pancreas, kidney, stomach, and thymus. Additionally, there was a single case of multiple myeloma and three unspecified diseases. Of the primary caregivers, nine were either a spouse or mate, three were parents, six were a son or daughter, two were other family relations, and, for two, the relationship was not identified.
Prevalence
Nineteen of the twenty-two (86%) surveyed patients with persistent pain reported experiencing breakthrough pains on a regular and recurring basis. About one-half of these pains were described as predictably occurring in association with a specific activity, fitting the term, “incident pain.”
Pain Locations
A wide range of discrete pain locations was reported (one to nine sites) by each patient. In order of frequency, these included the low back, abdomen, pelvis, leg(s), chest, arm(s), neck, shoulders, upper back, feet, flank, head, face, rectum or anus, and one unspecified site. The mean number of sites reported was 2.5.
Pain Descriptors
The most common breakthrough pain descriptors were “sharp” and “radiating/shooting.” The terms “pressure/squeezing/tight,” “aching,” and “burning” were used less frequently, and “throbbing,” “crampy,” “stabbing” and “other” were reported by a few patients. The mean number of descriptors used was 1.6, with two descriptors being listed most commonly.
Diurnal Variation in Pain
Breakthrough pain occurred during the day in 86% of patients and during the night in 45% of cases. These pains were reported as occurring every day in 50% of patients and every night in 22% of patients.
Usual (Baseline) Pain Intensity
Pain scores were assessed using a 0–10 analogue scale. Average, or usual, baseline day time pain ratings were reported as a mean of 3.6, a mode of 5. One patient exceeded a 5/10 pain rating, reporting his “usual” pain to be 8/10, but this actually reflected the intensity of his breakthrough pain, which was, indeed, his most “usual” pain, illuminating an ambiguity associated with communication. Of the patients reporting night time pain, the mean intensity was 2.5.
Fixed Schedule Opioid Analgesics
Nineteen of the twenty-two patients surveyed reported using one or more analgesics on a regular schedule. Ten used continuous or sustained release morphine, four used transdermal fentanyl patches, two used oral or intravenous methadone, two used hydrocodone, two used continuous release oxycodone, and one patient used intrathecal morphine.
Breakthrough Pain Interventions
Use of short-acting oral opioid formulations were the most common means of relieving breakthrough pains. Seven patients reported using hydrocodone, five used concentrated oral morphine solution, and four used oxycodone. One each used oral methadone, intravenous methadone, or intrathecal morphine. Three patients relied upon acetaminophen.
Other psychological or physical modalities used were ultrasound, relaxation, repositioning, ice, heat, massage, bathing, or a cool cloth compress. Two patients reported using neither analgesics nor other modalities to relieve their symptoms.
A wide variation in reported time to pain relief was evident, ranging from 5 min to 60 min (Figure 1).
Fig. 1.Time to relief in 19 home hospice patients with breakthrough pain
Breakthrough Pains: Characteristics and Patient–Caregiver Concordance
The frequency, intensity, and duration of episodic pains are tabulated in Table 1. Findings comparing patients’ reports and their caregivers’ observations are presented in Table 2.
Table 2Concordance of Caregivers to Patients, No. (%)
Baseline pain
Breakthrough pain
Estimates
UPI Day
UPI Night
No. episodes
Duration (min)
Severity
Amount of relief
Minutes to relief
Caregiver overestimates
3 (14)
5 (24)
6 (30)
6 (32)
6 (29)
8 (38)
4 (20)
Caregiver underestimates
6 (29)
4 (19)
9 (45)
9 (47)
9 (43)
5 (24)
10 (50)
Concordance
12 (57)
12 (57)
5 (25)
4 (21)
6 (29)
8 (38)
6 (30)
UPI, usual pain intensity; values reported represent the number of caregivers who overestimated or underestimated patients’ scores by at least 2 points on a 0 to 10-point analogue scale.
The results of this study strongly suggest that breakthrough pain is a very common occurrence in hospice patients with otherwise well-controlled underlying continuous pain problems from a variety of causes. Although this is a smaller sample, it appears that the incidence of breakthrough pain in hospice patients is higher than in the cancer population reported by Portenoy and Hagen.
about one-half the occurrences of breakthrough pain were precipitated (that is, incident pain), and therefore predictable to some degree.
It is noteworthy that persistent pain ratings and frequency of breakthrough pains demonstrate diurnal variation, with lessening during nighttime hours. This observation corroborates the findings of Bruera et al.
who documented a similar pattern of diurnal variation in opioid analgesic requirements in a palliative care unit. It would be premature to put too much stock in speculation about this observation until more studies assess this phenomenon. However, it suggests that continuous and breakthrough pain, as matters of awareness, are not brought to patients’ conscious attention as avidly during sleep hours. Sleep may physiologically blunt the perceived intensity of breakthrough pains. As well, it may be that nocturnal pain, regardless of type or cause, is not recalled as vividly as those occurring during usual waking hours, when pain assessment interviews are carried out.
Because primary caregivers are often the ones responsible for offering or administering analgesics, it was viewed as important to assess their perceptions. The data (Table 2) suggest that caregivers usually underestimate patients’ self-reports of number, intensity, and duration of breakthrough pain episodes, as well as amount of time to relief from pain.
The methodology of this study lends itself to potential errors in interpretation in two ways. The data may be skewed in the direction of overestimation of breakthrough pain prevalence by focusing only on patients who acknowledge persistent pain. However, because previous studies
have evaluated family perceptions of patients’ pain and have demonstrated the prevalence of pain in patients with advanced cancer and other life-limiting diseases, we are confident that these data accurately reflect the experiences of most terminally ill patients. Conversely, these survey data might underestimate breakthrough pain prevalence by overlooking patients who do not complain of pain.
In summary, it appears that breakthrough pain is a predictable consequence of most advanced cancers, and perhaps many other progressive, life-limiting disease processes, and it seems that these pains tend to become more prevalent as patients progress toward the terminal phase of their respective disease. These observations logically lead to the assertion that assessment and treatment for breakthrough pains in this population should be the rule. Caregivers need to be educated in how to match their perceptions with what is actually occurring in those for whom they are caring so that preventative and therapeutic interventions can be optimized.
Based upon the prevalence, frequency, intensity and duration of breakthrough pains, it can further be concluded that cancer patients, as well as other populations at risk for this problem, require specifically tailored therapeutic tools.
The development of analgesic formulations and drug delivery systems which allow noninvasive administration, rapid absorption for quick onset, individual and episodic titration, and have a short to moderate effective duration should greatly contribute to the improved well-being of these patients. For example, a product now under review by the U.S. Food and Drug Administration, oral transmucosal fentanyl citrate (OTFC), with these characteristics has been tested extensively in both postoperative and cancer pain populations, and appears to offer meaningful relief of breakthrough pain within 5 min, equivalent to intravenous (patient controlled analgesia) morphine.
Simmonds MA. Oral transmucosal fentanyl citrate produces pain relief faster than medication typically used for breakthrough pain in cancer patients. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
Lyss AP. Long-term use of oral transmucosal fentanyl citrate (OTFC) for breakthrough pain in cancer patients. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
Coluzzi P. A titration study of oral transmucosal fentanyl citrate for breakthrough pain in cancer patients. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
Cleary JF. Double-blind randomized study of the treatment of breakthrough pain in cancer patients: Oral transmucosal fentanyl citrate vs placebo. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
This work was funded by a grant from Anesta Corp., Salt Lake City, Utah, USA.
The authors gratefully acknowledge the generous support of the staff at Anesta Corp. and the dedicated nurses of Community Nursing Service and VistaCare.
References
Bonica JJ. Cancer pain. In: Bonica JJ, ed. The management of pain. Philadelphia; Lea and Febiger, 1990:400–434.
Simmonds MA. Oral transmucosal fentanyl citrate produces pain relief faster than medication typically used for breakthrough pain in cancer patients. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
Lyss AP. Long-term use of oral transmucosal fentanyl citrate (OTFC) for breakthrough pain in cancer patients. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
Coluzzi P. A titration study of oral transmucosal fentanyl citrate for breakthrough pain in cancer patients. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
Cleary JF. Double-blind randomized study of the treatment of breakthrough pain in cancer patients: Oral transmucosal fentanyl citrate vs placebo. American Society of Clinical Oncology (ASCO) Annual Meeting, 1997.
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