Relationship between time to onset of relief and total pain relief of breakthrough pain in patients with cancer using fentanyl pectin nasal spray.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19544-e19544
Author(s):  
John D. Conroy ◽  
Luis M. Torres ◽  
Julia Revnic ◽  
Ravi Tayi ◽  
Michael Sidney Perelman ◽  
...  

e19544 Background: Breakthrough pain in cancer (BTPc) is typified by a rapid onset of severe pain with a limited duration. Treatment for BTPc requires rapid onset of pain relief. The main purpose of this analysis was to assess the relationship between time to onset of pain relief and overall pain relief in patients treating BTPc with fentanyl pectin nasal spray (FPNS, Lazanda, PecFent). Methods: Data were pooled from FPNS-treated episodes of 2 randomized, double-blind, crossover studies assessing efficacy of FPNS in adults who experienced BTPc despite background pain that was adequately controlled with at least 60 mg/day morphine (or equivalent). Patients initially entered a dose-titration phase to establish dose of FPNS (100 to 800 mcg) to be used during the treatment phase of each study. Pain intensity (PI) was assessed at baseline and scheduled time points on an 11-point scale (0=no pain, 10=worst possible pain). This analysis assessed the relationship of time to onset of pain relief (≥1 point reduction in PI from baseline) to total pain relief (Summed Pain Intensity Difference [SPID] at 30 and 60 min postdose [SPID30 and SPID60]) by ANOVA. Responses are also provided for the placebo-treated episodes during the placebo-controlled trial. Results: There were 831 episodes of BTPc that were treated with FPNS. Mean SPID was highest when pain relief was earliest (p<0.001). When PI difference (PID) ≥1 was attained by 5, 10, and 15 min postdose, mean (SD) SPID30 scores were 13.1 (6.7), 7.6 (4.0), and 3.5 (1.8). In the placebo-controlled trial, a similar overall response (p<0.001) was observed during the 200 placebo-treated episodes: among those attaining PID ≥1 by 5, 10, and 15 min postdose, SPID30 was 12.2 (7.0), 5.3 (3.3), and 2.5 (1.0), respectively. Similarly, significant differences were observed for SPID60 with both treatments. Conclusions: Earlier time to onset of pain intensity reduction in BTPc treatment resulted in higher SPID at 30 and 60 minutes postdose of FPNS and placebo. Results suggest that early onset of relief may be associated with a greater overall degree of relief for episodes of BTPc, which emphasizes the need for rapid-acting agents in the management of breakthrough pain.

2014 ◽  
Vol 17 (10) ◽  
pp. 1150-1157 ◽  
Author(s):  
Luis M. Torres ◽  
Julia Revnic ◽  
Alastair D. Knight ◽  
Michael Perelman

2021 ◽  
Author(s):  
Liang Zhou ◽  
Zhenggang Guo

Abstract Background and Objectives: Intrathecal analgesia (ITA) is a trusty treatment option for refractory and intractable cancer pain. However, there is still no general consensus on the analgesic effect of movement-evoked breakthrough pain (MEBTP) in the ITA setting. This study examined the effect of patient-controlled intrathecal analgesia (PCIA) on analgesic efficacy, emphasizing movement evoked breakthrough pain (MEBTP) in patients with refractory lower extremity cancer pain. Methods: A retrospective chart review included all patients with refractory lower extremity cancer pain who received Intrathecal morphine infusion therapy via percutaneous port (IMITPP) at our hospital between January 2017 and December 2020. Data on the numerical pain rating scales (NRS) scores, opioid doses, and complications were collected from medical records prior to IMITPP and at a one-month postimplant visit.Results: A total of 16 patients were included in the study group. Mean SRPI (spontaneous resting pain intensity) decreased from 8.75 pre- IMITPP to 3.75 post- IMITPP, (P < 0.001); mean MEPI (movement-evoked breakthrough pain intensity) fell from 8.83 pre- IMITPP to 4.25 post- IMITPP (P < 0.001); mean daily morphine equivalent dosing decreased from 360 mg/d to 48mg/d (P< 0.001); mean daily morphine equivalent dosing for MEBTP decreased from 87 mg/d to 6 mg/d (P< 0.001). Both total and breakthrough dosing of conventional opioid medications significantly decreased following the initiation of ITT with PCIA. The mean perceived time to onset with conventional movement evoked breakthrough medications was 38 minutes, and the mean perceived time to onset with PCIA was 8 minutes (P < 0.001). Conclusions: IMITPP was associated with improved pain control in patients with refractory lower extremity cancer pain. Compared with conventional MEBTP medication, appropriate PCIA provided superior analgesia and a much faster onset of action.


2011 ◽  
Vol 29 (15_suppl) ◽  
pp. e19659-e19659
Author(s):  
A. Nguyen ◽  
A. W. Burton ◽  
J. Conroy ◽  
N. Y. Gabrail

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9563-9563
Author(s):  
Donald Taylor ◽  
Lukas Radbruch ◽  
Julia Revnic ◽  
Luis M. Torres ◽  
John E Ellershaw ◽  
...  

9563 Background: Given that patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. The objective of this study was to investigate the use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients taking regular opioid therapy. Methods: A total of 401 adult patients, taking at least 60 mg/day oral morphine or equivalent, with an average of 1 to 4 episodes of BTPc per day, who were either newly enrolled or had completed a randomized controlled trial with FPNS, entered into an open-label assessment study (NCT00458510). Of these, 171 patients, continued into an extension period. Up to 4 episodes of BTPc per day were treated with FPNS at titrated doses between 100 µg and 800 µg. Patients returned to the clinic at 4-week intervals for assessment and reporting of any adverse events (AEs). Results: There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for more than 1 year, while the maximum duration was 3 years and 8 months. In total, 2% of patients withdrew from the study due to lack of efficacy. Seventy-four percent of patients did not change their FPNS dose. The most common AEs, aside from disease progression, were: insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of treatment-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced treatment-related nasal AEs, which, with the exception of 1 severe event, were all mild or moderate. Conclusions: FPNS appeared to provide a sustained benefit and was well tolerated during the long-term treatment of BTPc. Clinical trial information: NCT00458510.


2005 ◽  
Vol 103 (6) ◽  
pp. 1225-1232 ◽  
Author(s):  
Maria Soledad Cepeda ◽  
Daniel B. Carr ◽  
Nelcy Miranda ◽  
Adriana Diaz ◽  
Claudia Silva ◽  
...  

Background Meta-analyses report similar numbers needed to treat for nonsteroidal antiinflammatory drugs (NSAIDs) and opioids. Differences in baseline pain intensity among the studies from which these numbers needed to treat were derived may have confounded the results. NSAIDs have an opioid-sparing effect, but the importance of this effect is unclear. Therefore, the authors sought to compare the proportions of subjects who obtain pain relief with ketorolac versus morphine after surgery and to determine whether the opioid-sparing effect of an NSAID reduces the magnitude of opioid side effects. Methods The study was a double-blind, randomized controlled trial. The authors randomly assigned 1,003 adult patients to receive 30 mg ketorolac or 0.1 mg/kg morphine intravenously. They calculated the proportion of subjects who achieved at least 50% reduction in pain intensity 30 min after analgesic administration. Further, so long as pain intensity 30 min after analgesic administration was 5 or more out of 10, patients received 2.5 mg morphine every 10 min until pain intensity was 4 or less out of 10. The authors assessed the presence of opioid-related side effects. Results Five hundred patients received morphine and 503 received ketorolac. Fifty percent of patients in the morphine group achieved pain relief, compared with 31% in the ketorolac group (difference, 19%; 95% confidence interval, 13-25%). The ketorolac-morphine group required less morphine (difference, 6.5 mg; 95% confidence interval, -5.8 to -7.2) and had a lower incidence of side effects (difference, 11%; 95% confidence interval, 5-16%) than the morphine group. Conclusions Opioids are more efficacious analgesics than NSAIDs, although historic data for these two drugs yield similar numbers needed to treat. Adding NSAIDs to the opioid treatment reduces morphine requirements and opioid-related side effects in the early postoperative period.


2013 ◽  
Vol 9 (4) ◽  
pp. 255-262 ◽  
Author(s):  
Lena Lundorff, MD ◽  
Per Sjøgren, DmSci, MD ◽  
Ole Bo Hansen, MD ◽  
Torsten Jonsson, MD ◽  
Per Rotbøll Nielsen ◽  
...  

Background: Several myths on buprenorphine’s pharmacology exist: possible analgesic ceiling effect, feasibility of combination with other opioid agonists, and the reversibility of side effects. Aim to evaluate: 1) if cancer patients receiving high doses of pure agonists could obtain adequate pain relief after switching to transdermal (TD) buprenorphine and 2) whether the numbers of breakthrough pain episodes after switching increased and whether they could be treated with the same doses of pure agonist as before switching.Design: The prospective open multicenter study included outpatients with moderate-to-severe cancer pain satisfactorily controlled.Setting: Patients were switched from the usual pure agonist to TD buprenorphine and were titrated to a stable dose. The assessments were: 1) daily self-assessment of pain intensity, numbers of rescue medications, and pain interference with sleep; 2) brief pain inventory; 3) pain relief and pain intensity; 4) quality of life; and 5) adverse events and symptoms.Results: Eighteen patients receiving 150-516 mg of morphine/day were included. The buprenorphine dose at the end of the study varied between 52.5 and 140 mg/h. No difference in pain before and after switching was shown. The level of rescue doses was maintained. The patches were well tolerated. A significant decrease in fatigue and an increase in global health status were seen after the switch.Conclusion: It is feasible to switch cancer patients from high doses of pure µ- opioid agonists to TD buprenorphine without eliciting any antagonist effects, but the dose conversion factor is individual and the switching process should be tailored for the individual patient.


1999 ◽  
Vol 91 (1) ◽  
pp. 34-41 ◽  
Author(s):  
Martin S. Angst ◽  
William G. Brose ◽  
John B. Dyck

Background Most analgesic drug studies in humans quantify drug action based on verbal reports of pain intensity and pain relief. Although measures of pain intensity and pain relief show a good overall correlation, it is not known if they relate to each other consistently over time Such consistency is necessary if both measures are used to depict analgesic drug action versus time. This study examined in chronic pain patients if the relationship between visual analog pain intensity and pain relief scores was consistent during two analgesic drug studies. Methods Data from two independently performed analgesic drug studies were analyzed using linear regression. Data were split into pain intensity and pain relief scores recorded before and after patients' experience of maximum analgesia (&gt;90% of maximum pain relief). The slopes of the linear regression line depicting pain intensity versus pain relief scores before and after maximum analgesia were statistically compared. Results The slope of the linear regression line before and after maximum analgesia was significantly different in both drug studies (nonoverlapping 95% confidence intervals), -2.16+/-0.57 versus -1.05+/-0.10 and -1.47+/-0.26 versus -1.09+/-0.07, respectively. These results are compatible with the observation that patients indicating the same pain intensity before and after maximum analgesia reported a different magnitude of pain relief. Conclusions The relationship between visual analog pain intensity and pain relief scores changed systematically during both analgesic drug studies. The authors hypothesize that patients' interpretation of the pain relief scale had changed during the studies and therefore suggest using the pain intensity scale to quantify analgesic drug action over time.


2014 ◽  
Vol 42 (02) ◽  
pp. 289-302 ◽  
Author(s):  
Ke Zeng ◽  
Hui-Juan Dong ◽  
Hong-Yun Chen ◽  
Zhe Chen ◽  
Bai Li ◽  
...  

This study was designed to evaluate the analgesic effect of wrist-ankle acupuncture (WAA) for patients with primary liver cancer (PLC) after transcatheter arterial chemoembolization (TACE). Sixty PLC patients with post-TACE visual analog pain intensity scores greater than 3 were divided equally into two groups receiving either WAA or oral morphine sulphate (MOR) for post-TACE pain. Pain intensity scores were reassessed at 1, 2, 4, and 6 h after analgesic intervention. Patients were also monitored for adverse reactions to analgesic treatment. Pain scores recorded when the patients first felt pain after TACE showed no statistical difference between the two groups (p > 0.05). WAA and MOR had indistinguishable degrees of pain relief 1, 2, and 4 h after analgesic intervention (p > 0.05). At 6 h after intervention, the WAA group experienced significantly greater pain relief than the MOR group (p < 0.05). Incidence of abdominal distension was lower in the WAA group than in the MOR group (p < 0.05). The results suggest that WAA not only had an analgesic effect equal to or greater than MOR in PLC patients with moderate to severe post-TACE pain, but also reduced the incidence of post-operative abdominal distention.


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