Convenience of Iontophoretic Transdermal Fentanyl Versus Morphine IV PCA
Convenience of Iontophoretic Transdermal Fentanyl Versus Morphine IV PCA
The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is a compact, self-contained, needle-free system that has been approved for acute postoperative pain management in hospitalized adults. The objective of the present analysis was to evaluate patients' assessment of fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) convenience on 7 different subscales, using a validated patient ease of care (EOC) questionnaire in 2 prospective, open-label, randomized, phase IIIb clinical trials. Patients received fentanyl ITS or morphine IV PCA (N = 1,305) for up to 72 h after total hip replacement surgery (THR study) or abdominal or pelvic surgery (APS study). For the majority of items on the patient EOC questionnaire, trends suggest that greater percentages of patients reported the most positive response for fentanyl ITS than they did for morphine IV PCA in both studies; differences were particularly noteworthy for items on the Movement subscale. In the THR study, more patients in the fentanyl ITS group were responders compared with those in the morphine IV PCA group for the subscales Confidence with Device, Pain Control, Knowledge/Understanding, and Satisfaction. In the APS study, responder rates for these subscales did not differ between treatment groups. These findings indicate that patients assessed the EOC associated with fentanyl ITS higher compared with morphine IV PCA for the management of acute postoperative pain and suggest that fentanyl ITS has the potential to improve acute postoperative pain care for patients and nurses.
Pain is a common and expected outcome after surgery. Although various pain management guidelines have been developed (American Pain Society, 2003; American Society of Anesthesiologists Task Force on Acute Pain Management et al., 2004; Gordon et al., 2005; Rathmell et al., 2006), recent studies show that inadequate management of postoperative pain remains a concern (Apfelbaum et al., 2003; Bertolini et al., 2002; Puig et al., 2001; Ritchey, 2006). Ineffective postoperative pain management can have serious consequences, including the development of chronic pain (Chen et al., 2001; Donovan et al., 1987; Warfield & Kahn, 1995) and complicated or prolonged patient recovery (Chen et al., 2001; Donovan et al., 1987; Sinatra et al., 2002; Warfield & Kahn, 1995). In addition to pain control, other aspects of patient care should be taken into account when considering different modalities for effective postoperative pain management, including patient preference, ease of use and convenience, and patient mobility, because these factors may contribute to overall patient satisfaction and promote recovery. Patients prefer patient-controlled analgesia (PCA) to clinician-controlled analgesic administration (Lehmann, 1999) for several reasons, including greater control over pain management (Ballantyne et al., 1993), a sense of better pain relief (Chumbley et al., 1999), avoidance of side effects commonly associated with the administration of large bolus doses (Chumbley et al., 1999), and prevention of potential overdose (Chumbley et al., 1999). Patient-controlled analgesia also allows patients to self-administer analgesia in small fixed doses according to their individual needs; reduces gaps in pain relief owing to delays in administration that may occur with nurse-administered intermittent dosing strategies (e.g., intramuscular administration [Carr et al., 2005]); and provides doses sufficient to reach the minimum effective analgesic threshold but small enough to avoid some of the adverse events (AEs) associated with peaks in serum concentrations (Etches, 1999).
Intravenous (IV) PCA with morphine is commonly used in the postoperative setting and, although effective, has certain limitations. It requires patients to be tethered by IV tubing and an electric cord (connected to a dosing button) to a pump apparatus, hindering their mobility and limiting the potential for optimal recovery (Markey & Brown, 2002). Also, IV access is required, causing discomfort to the patient and raising the associated risks of needle-related complications (Wilburn, 2004). Furthermore, PCA pumps are manually programmed, allowing for errors that could result in improper analgesia administration (Doyle, 2003; Eisenach, 2002; Hicks et al., 2004; Macintyre, 2001).
A novel PCA therapy, the patient-controlled fentanyl HCl iontophoretic transdermal system (fentanyl ITS; IONSYS™; Ortho-McNeil, Raritan, NJ), has recently been approved for acute postoperative pain management in hospitalized adult patients and addresses some limitations of IV PCA. Fentanyl ITS is a compact, self-contained, needle-free system that delivers fentanyl via iontophoresis, a process in which a low-intensity electrical field is used to transport ionized fentanyl molecules across intact skin. The system is applied to the upper outer arm or chest and delivers a preprogrammed dose of fentanyl (40 μg) into the bloodstream. The efficacy and safety of fentanyl ITS has been demonstrated in several placebo- and activecontrolled clinical trials (Chelly et al., 2004; Viscusi et al., 2004; Viscusi et al., 2006b); however, those studies did not evaluate certain aspects of patient care, including ease of use, impact on mobility, and patient comfort. Two phase IIIb trials evaluated the efficacy and safety of the fentanyl ITS compared with morphine IV PCA in patients who underwent total hip replacement surgery (THR study; Hartrick et al., 2006) or abdominal or pelvic surgery (APS study; Minkowitz et al., 2007). In addition, separate, validated patient, nurse, and physical therapist ease of care (EOC) questionnaires (Harding et al., 2007; Viscusi et al., 2006a) were used in those studies to evaluate the EOC with each modality from the perspectives of the patient, nurse, and physical therapist, respectively.
Most analgesic studies assess patient-reported pain control, patient discontinuation rates, and patient satisfaction (Lehmann, 2005). However, the value of pain management techniques (particularly with modern treatment modalities) also depends on other important factors. Patients and nurses should be comfortable with the level of technology for a treatment modality to be practical for use in an everyday clinical setting. In particular, the activation of drug delivery (if patient controlled [Ferrante et al., 1988; Jamison et al., 1993; Magnani et al., 1989; Thomas et al., 1998]) must be simple and easy to understand. The level of patient movement that a treatment modality allows is also important to consider, because mobility is critical for optimal recovery from many surgical procedures (Markey & Brown, 2002). Finally, assessing how time consuming and cumbersome the modality is to operate is also essential, because modalities that require too much nursing time or place undue burden on nurses may compromise the quality of patient care (Aiken et al., 2001). The EOC questionnaires used in the trials were designed to capture these important variables for comparing the clinical utility of newly developed and existing modalities of pain control.
Results from the patient, nurse, and physical therapist EOC questionnaires during the THR and APS studies have been previously reported. Briefly, responses recorded on the patient, nurse, and physical therapist EOC questionnaires indicated that overall EOC was superior for fentanyl ITS compared with morphine IV PCA from the perspectives of patients, nurses, and physical therapists in the THR study (Hartrick et al., 2006) and the APS study (Minkowitz et al., 2007). Data from the patient EOC questionnaire also indicated that patient mobility was superior with fentanyl ITS versus morphine IV PCA; however, an extensive analysis of the data collected using the patient EOC questionnaire was not conducted. The objective of the present report was to assess the convenience of each pain management modality, as measured using the patient EOC questionnaire from both the THR and the APS studies. Because surgery type may impact the completion of daily tasks, it is important to note that these results were from 2 studies that evaluated the fentanyl ITS versus morphine IV PCA after different surgery types.
Abstract and Introduction
Abstract
The patient-controlled fentanyl HCl iontophoretic transdermal system (ITS) is a compact, self-contained, needle-free system that has been approved for acute postoperative pain management in hospitalized adults. The objective of the present analysis was to evaluate patients' assessment of fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) convenience on 7 different subscales, using a validated patient ease of care (EOC) questionnaire in 2 prospective, open-label, randomized, phase IIIb clinical trials. Patients received fentanyl ITS or morphine IV PCA (N = 1,305) for up to 72 h after total hip replacement surgery (THR study) or abdominal or pelvic surgery (APS study). For the majority of items on the patient EOC questionnaire, trends suggest that greater percentages of patients reported the most positive response for fentanyl ITS than they did for morphine IV PCA in both studies; differences were particularly noteworthy for items on the Movement subscale. In the THR study, more patients in the fentanyl ITS group were responders compared with those in the morphine IV PCA group for the subscales Confidence with Device, Pain Control, Knowledge/Understanding, and Satisfaction. In the APS study, responder rates for these subscales did not differ between treatment groups. These findings indicate that patients assessed the EOC associated with fentanyl ITS higher compared with morphine IV PCA for the management of acute postoperative pain and suggest that fentanyl ITS has the potential to improve acute postoperative pain care for patients and nurses.
Introduction
Pain is a common and expected outcome after surgery. Although various pain management guidelines have been developed (American Pain Society, 2003; American Society of Anesthesiologists Task Force on Acute Pain Management et al., 2004; Gordon et al., 2005; Rathmell et al., 2006), recent studies show that inadequate management of postoperative pain remains a concern (Apfelbaum et al., 2003; Bertolini et al., 2002; Puig et al., 2001; Ritchey, 2006). Ineffective postoperative pain management can have serious consequences, including the development of chronic pain (Chen et al., 2001; Donovan et al., 1987; Warfield & Kahn, 1995) and complicated or prolonged patient recovery (Chen et al., 2001; Donovan et al., 1987; Sinatra et al., 2002; Warfield & Kahn, 1995). In addition to pain control, other aspects of patient care should be taken into account when considering different modalities for effective postoperative pain management, including patient preference, ease of use and convenience, and patient mobility, because these factors may contribute to overall patient satisfaction and promote recovery. Patients prefer patient-controlled analgesia (PCA) to clinician-controlled analgesic administration (Lehmann, 1999) for several reasons, including greater control over pain management (Ballantyne et al., 1993), a sense of better pain relief (Chumbley et al., 1999), avoidance of side effects commonly associated with the administration of large bolus doses (Chumbley et al., 1999), and prevention of potential overdose (Chumbley et al., 1999). Patient-controlled analgesia also allows patients to self-administer analgesia in small fixed doses according to their individual needs; reduces gaps in pain relief owing to delays in administration that may occur with nurse-administered intermittent dosing strategies (e.g., intramuscular administration [Carr et al., 2005]); and provides doses sufficient to reach the minimum effective analgesic threshold but small enough to avoid some of the adverse events (AEs) associated with peaks in serum concentrations (Etches, 1999).
Intravenous (IV) PCA with morphine is commonly used in the postoperative setting and, although effective, has certain limitations. It requires patients to be tethered by IV tubing and an electric cord (connected to a dosing button) to a pump apparatus, hindering their mobility and limiting the potential for optimal recovery (Markey & Brown, 2002). Also, IV access is required, causing discomfort to the patient and raising the associated risks of needle-related complications (Wilburn, 2004). Furthermore, PCA pumps are manually programmed, allowing for errors that could result in improper analgesia administration (Doyle, 2003; Eisenach, 2002; Hicks et al., 2004; Macintyre, 2001).
A novel PCA therapy, the patient-controlled fentanyl HCl iontophoretic transdermal system (fentanyl ITS; IONSYS™; Ortho-McNeil, Raritan, NJ), has recently been approved for acute postoperative pain management in hospitalized adult patients and addresses some limitations of IV PCA. Fentanyl ITS is a compact, self-contained, needle-free system that delivers fentanyl via iontophoresis, a process in which a low-intensity electrical field is used to transport ionized fentanyl molecules across intact skin. The system is applied to the upper outer arm or chest and delivers a preprogrammed dose of fentanyl (40 μg) into the bloodstream. The efficacy and safety of fentanyl ITS has been demonstrated in several placebo- and activecontrolled clinical trials (Chelly et al., 2004; Viscusi et al., 2004; Viscusi et al., 2006b); however, those studies did not evaluate certain aspects of patient care, including ease of use, impact on mobility, and patient comfort. Two phase IIIb trials evaluated the efficacy and safety of the fentanyl ITS compared with morphine IV PCA in patients who underwent total hip replacement surgery (THR study; Hartrick et al., 2006) or abdominal or pelvic surgery (APS study; Minkowitz et al., 2007). In addition, separate, validated patient, nurse, and physical therapist ease of care (EOC) questionnaires (Harding et al., 2007; Viscusi et al., 2006a) were used in those studies to evaluate the EOC with each modality from the perspectives of the patient, nurse, and physical therapist, respectively.
Most analgesic studies assess patient-reported pain control, patient discontinuation rates, and patient satisfaction (Lehmann, 2005). However, the value of pain management techniques (particularly with modern treatment modalities) also depends on other important factors. Patients and nurses should be comfortable with the level of technology for a treatment modality to be practical for use in an everyday clinical setting. In particular, the activation of drug delivery (if patient controlled [Ferrante et al., 1988; Jamison et al., 1993; Magnani et al., 1989; Thomas et al., 1998]) must be simple and easy to understand. The level of patient movement that a treatment modality allows is also important to consider, because mobility is critical for optimal recovery from many surgical procedures (Markey & Brown, 2002). Finally, assessing how time consuming and cumbersome the modality is to operate is also essential, because modalities that require too much nursing time or place undue burden on nurses may compromise the quality of patient care (Aiken et al., 2001). The EOC questionnaires used in the trials were designed to capture these important variables for comparing the clinical utility of newly developed and existing modalities of pain control.
Results from the patient, nurse, and physical therapist EOC questionnaires during the THR and APS studies have been previously reported. Briefly, responses recorded on the patient, nurse, and physical therapist EOC questionnaires indicated that overall EOC was superior for fentanyl ITS compared with morphine IV PCA from the perspectives of patients, nurses, and physical therapists in the THR study (Hartrick et al., 2006) and the APS study (Minkowitz et al., 2007). Data from the patient EOC questionnaire also indicated that patient mobility was superior with fentanyl ITS versus morphine IV PCA; however, an extensive analysis of the data collected using the patient EOC questionnaire was not conducted. The objective of the present report was to assess the convenience of each pain management modality, as measured using the patient EOC questionnaire from both the THR and the APS studies. Because surgery type may impact the completion of daily tasks, it is important to note that these results were from 2 studies that evaluated the fentanyl ITS versus morphine IV PCA after different surgery types.
