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1.
Pain Manag Nurs ; 23(4): 411-417, 2022 08.
Article in English | MEDLINE | ID: mdl-35305935

ABSTRACT

BACKGROUND: Several clinical practice guidelines (CPGs), consensus statements, and recommendations currently exist for the diagnosis and management of breakthrough cancer pain (BTcP). These documents have considerable variability amongst them, and to date, their quality and methodologic rigor have not been appraised. AIM: We aim to identify and perform a quality appraisal of CPGs for the diagnosis and management of BTcP using the Appraisal of Guidelines for Research and Evaluation (AGREE II) tool. METHODS: A comprehensive literature search was performed in MEDLINE (via PubMed), EMBASE, and SCOPUS databases up until January 1, 2021. Four reviewers independently evaluated each guideline using the AGREE II instrument. Scaled domain scores were generated and the threshold used for satisfactory quality was >60%. Additionally, intraclass correlation coefficients (ICC) were calculated to determine level of agreement between reviewers. RESULTS: Eleven guidelines were selected for final evaluation based on inclusion/exclusion criteria. Only one guideline was classified of "average" quality while the rest were classified as "low" quality. The "Editorial Independence" (70.46 ± 35.7) and "Scope and Purpose" (64.78 ± 12.5) domains received the highest mean scores, while the "Applicability" (32.58 ± 13.5) and "Rigor of Development" (35.04 ± 9.0) domains received the lowest mean scores. ICC statistical analysis showed high magnitude of agreement between reviewers with a range of (0.790-0.988). CONCLUSIONS: Reflecting upon our quality appraisal, it is evident that the quality and methodologic rigor of BTcP guidelines can be improved upon in the future. Our findings also elucidate the existing variability/discrepancies among guidelines in diagnostic criteria and management of BTcP.


Subject(s)
Breakthrough Pain , Cancer Pain , Neoplasms , Breakthrough Pain/diagnosis , Breakthrough Pain/drug therapy , Cancer Pain/therapy , Databases, Factual , Humans , Neoplasms/complications , Practice Guidelines as Topic
2.
Curr Opin Anaesthesiol ; 32(3): 307-314, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31045638

ABSTRACT

PURPOSE OF REVIEW: Neuraxial techniques are the current gold standard for labour analgesia, but are associated with up to 25% incidence of breakthrough pain. In this review, we aim to update clinicians on the latest research pertaining to the optimization of neuraxial labour analgesia. RECENT FINDINGS: Attempts to improve the efficacy and reliability of epidural analgesia while minimizing adverse effects have resulted in the rising popularity of combined spinal epidural and the dural puncture epidural (DPE). Recent studies have focused on determining the safety, efficacy, and optimization of the DPE technique.Another research focus is on the development of individualized therapy in which patients may titrate their own labour analgesia according to their varying requirements, possibly augmented with computer-aided feedback systems and automated mandatory bolus techniques that automatically adjust drug delivery to the patients' analgesic requirements. The addition of a risk-stratification model based on maternal, anaesthetic, and obstetric factors will facilitate early institution of individualized therapy to forestall breakthrough pain in higher risk patients. SUMMARY: Recent advances in combined spinal epidural, DPE, automated mandatory bolus, and individualized therapies have advanced our goal of providing effective labour analgesia that is titrated to changing analgesic requirements during labour and delivery and reducing breakthrough pain.


Subject(s)
Analgesia, Epidural/methods , Analgesia, Obstetrical/methods , Anesthetics, Local/administration & dosage , Breakthrough Pain/therapy , Analgesia, Epidural/adverse effects , Analgesia, Epidural/instrumentation , Analgesia, Obstetrical/adverse effects , Analgesia, Obstetrical/instrumentation , Breakthrough Pain/diagnosis , Breakthrough Pain/etiology , Dose-Response Relationship, Drug , Female , Humans , Infusion Pumps , Monitoring, Physiologic/methods , Pregnancy , Treatment Outcome
3.
BMC Palliat Care ; 17(1): 81, 2018 May 28.
Article in English | MEDLINE | ID: mdl-29807537

ABSTRACT

BACKGROUND: Breakthrough cancer pain (BTcP) is defined according to its principal characteristics: high intensity, short time interval between onset and peak intensity, short duration, potential recurrence over 24 h and non-responsiveness to standard analgesic regimes. The Edmonton Classification System for Cancer Pain (ECS-CP) is a classification tool that evaluates different dimensions of pain. The aim of this study was to measure prevalence and the main characteristics of BTcP in a sample of advanced cancer patients and to explore the complexity observed when ECS-CP is incorporated into BTcP diagnostics algorithm. METHODS: Descriptive prevalence study (Retrospective chart review). Davies' algorithm was used to identify BTcP and ECS-CP was used to recognize appropriate dimensions of pain. The study was conducted in a sample of advanced cancer patients attending hospital outpatient clinic in Lleida, Spain. 277 patients were included from 01/01/2014 to 31/12/2015. No direct contact was made with participants. The following information was extracted from the palliative care outpatient clinic database: age, gender, civil status, cognitive impairment status, functional performance status and variables related to tumour. Only BTcP cases were included. RESULTS: Prevalence of BTcP was 39.34% (63.9% men). Mean of age was 68.2 years. Main diagnosis was lung cancer (n = 154; 31.6%). Metastases were diagnosed in 83% of the sample. 138 patients (49.8%) were diagnosed with 1 type of BTcP and 139 (50.2%) were diagnosed with more than one type of BTcP. In total, 488 different types of BTcP were recorded (mean 1.75 ± 0, 9), 244 of these types (50%) presented a component of neuropathic pain. Addictive behaviour, measured through CAGE test, was present in 29.2% (N = 81) of the patients and psychological distress was present in 40.8% (n = 113). CONCLUSIONS: Prevalence of BTcP (39.34%) is similar to the one reflected in the existing literature. Study results indicate that the routine use of ECS-CP in a clinical setting allows us to detect more than one type of BTcP as well as additional complexity associated with pain (neuropathic, addictive behavior and psychological distress).


Subject(s)
Breakthrough Pain/diagnosis , Cancer Pain/diagnosis , Pain Measurement/methods , Aged , Algorithms , Breakthrough Pain/epidemiology , Cancer Pain/epidemiology , Female , Hospitals, Teaching , Humans , Lung Neoplasms/epidemiology , Lung Neoplasms/physiopathology , Male , Retrospective Studies , Spain/epidemiology
4.
J Cancer Educ ; 33(2): 284-292, 2018 04.
Article in English | MEDLINE | ID: mdl-27623849

ABSTRACT

This study sought to explore the association between physician practice patterns and patient education, with a focus on breakthrough cancer pain (BTcP). A nationwide online survey was conducted by 92 Korean physicians. Thirteen questions on Korean physician's assessment, prescription, patient education practices, and knowledge regarding BTcP were administered. Based on their responses, physicians were divided using two methods: (1) by their patient education practices, where the "education group" always explained the distinction between background pain and BTcP and the "less education group" which explained it less frequently; and (2) by their definition of BTcP, as occurring "after control of background pain" or "regardless of background pain." We compared practice patterns using Fisher's exact test or Student's t test and performed multiple logistic regression analysis. The "education group" (65 physicians, 70.7 %) was more likely than the "less education group" to assess BTcP meticulously (odds ratio [OR] 17.13, 95 % confidence interval [CI] 4.98-58.94), prepare rescue medications in advance (OR 3.67, 95 % CI 1.36-9.90), and give explicit instructions regarding medications (OR 36.68, 95 % CI 5.63-239.15). Physicians who defined BTcP as occurring "after control of background pain" were more likely to explain how to take rescue medication (P < 0.05) than physicians who defined BTcP as occurring "regardless of background pain." Korean physicians' BTcP practice patterns may be affected by whether they consistently educate patients on the distinction between background pain and BTcP, regardless of their knowledge of the definition of BTcP.


Subject(s)
Back Pain/diagnosis , Breakthrough Pain/diagnosis , Cancer Pain/diagnosis , Neoplasms/complications , Patient Education as Topic , Practice Patterns, Physicians'/standards , Adult , Back Pain/etiology , Breakthrough Pain/etiology , Cancer Pain/etiology , Diagnosis, Differential , Female , Humans , Male , Middle Aged , Neoplasms/therapy , Surveys and Questionnaires
5.
J Pak Med Assoc ; 68(7): 994-1001, 2018 Jul.
Article in English | MEDLINE | ID: mdl-30317290

ABSTRACT

OBJECTIVE: To reduce postoperative pain by using additional analgesic agent in between the usual parenteral analgesia that is used in the postoperative period in surgical patients. METHODS: The double-blind, randomised control intervention was conducted from June to November 2015 at Rehman Medical Institute, Peshawar, Pakistan, and comprised postoperative surgical patients of either gender aged 18 or more who had undergone uneventful elective surgery The subjects were divided into test and placebo groups. In the test group, 1gm acetaminophen was additionally prescribed, while in the control group placebo (starch) was administered. Demographics were noted and pain score was recorded using three internationally validated pain scales; Verbal pain intensity scale, Visual analogue scale, and Numeric pain scale. SPSS version 15.0 is used for calculation. Data was collected twice over 48 hours. RESULTS: Out of 220 patients, 165(75 %) were male with mean age 31.5±1.93 years and 55(25%) were female with mean age 31.5±1.48 years. There were 118(53.6%) patients in the test group and 102(43.4%) in the control group. In the first 24 hours the cumulative pain score, from numeric pain scale and visual analogue scale, for the control group showed 5(4.90%) patients had no pain, 39(38.24%) had mild pain, 52(50.98%) moderate pain and 6(5.80%) had severe pain. In the test group, 13(11.02%) reported no pain, 83(70.34%) had mild pain, 19(16%) had moderate pain while 3(2.54%) complained of severe pain. In the next 48 hours cumulative pain score in the test group showed 44(37.29%)subjects had no pain, 67(56.78%) had mild pain, 6(5.08%) had moderate pain, 1(0.85%) had severe pain, while in the control group 10(10%) had no pain, 56(55%) had mild pain, 33(32%) had moderate pain and 3(3%) had severe pain. . CONCLUSIONS: Additional acetaminophen reduced mild to moderate pain between two doses of parenteral analgesia.


Subject(s)
Acetaminophen/administration & dosage , Breakthrough Pain/drug therapy , Pain, Postoperative/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Analgesics, Non-Narcotic/administration & dosage , Breakthrough Pain/diagnosis , Dose-Response Relationship, Drug , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pain Measurement , Pain, Postoperative/diagnosis , Retrospective Studies , Treatment Outcome , Young Adult
6.
Ir Med J ; 108(6): 174-6, 2015 Jun.
Article in English | MEDLINE | ID: mdl-26182800

ABSTRACT

Breakthrough cancer pain (BTcP) is common, resulting in significant physical and psychosocial morbidity. We assessed the impact of BTcP on 81 cancer patients attending Irish specialist palliative care services. BTcP occurred up to twice daily in 24 (30%) and 3-4 times daily in 57 (70%) of cases. Median scores for the 'worst' and 'least' pains in the previous 24 hours were 7 and 2/10 respectively. Pain lasted < 15 minutes in 19 (23.5%), 15-30 minutes in 25 (30.8%), 30-60 minutes in 18 (22.2%) and > 60 minutes in 19 (23.5%) of patients. BTcP had a negative impact on general activity, mood, walking ability, work, relations with others, sleep and overall enjoyment of life. BTcP increased anxiety, depression, anger, isolation, financial difficulties and an inability to undergo cancer treatments. Systematic assessment of BTcP should form an integral part of every oncology/palliative medicine assessment. Once identified, BTcP should be managed assiduously.


Subject(s)
Breakthrough Pain/diagnosis , Neoplasms/complications , Pain Measurement/methods , Activities of Daily Living , Adult , Aged , Aged, 80 and over , Breakthrough Pain/etiology , Breakthrough Pain/physiopathology , Breakthrough Pain/psychology , Female , Humans , Male , Middle Aged , Palliative Care
7.
Eur J Cancer Care (Engl) ; 23(1): 121-8, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24079835

ABSTRACT

Poorly managed cancer pain is well known to profoundly impact the patient's daily life and interfere with quality of life. Nurses who cared for patients with cancer from 12 European countries participated in a survey of breakthrough cancer pain practice. The purpose was to investigate how nurses assess breakthrough cancer pain, use of standardised tools, confidence in supporting patients and awareness of medications. Responses from 1241 participants showed country variations. The majority of the sample was female, Germany had the highest proportion of male nurses (21.0%), followed by Greece (15.8%). A significantly larger proportion of nurses with longer experience and more education (78.8%) used a comprehensive definition of breakthrough cancer pain. Significant variations in training were found; 71% of Finnish nurses had received training compared with 6% of Greek nurses. Training and using a standardised assessment tool was associated with a significant increase in the nurses' perceived ability to distinguish between breakthrough and background pain. Nurses in countries with the highest proportion of training were most confident in supporting patients. In conclusion, there still exists problems with effective management of patients' breakthrough cancer pain, continuing inability to define the difference between background and breakthrough cancer pain leads to poor treatment.


Subject(s)
Breakthrough Pain/nursing , Health Knowledge, Attitudes, Practice , Neoplasms/complications , Oncology Nursing/methods , Pain Management/nursing , Adult , Aged , Breakthrough Pain/diagnosis , Breakthrough Pain/drug therapy , Clinical Competence , Education, Nursing/standards , Europe , Female , Humans , Male , Middle Aged , Neoplasms/nursing , Self Efficacy , Surveys and Questionnaires , Young Adult
8.
J Hand Surg Am ; 39(2): 324-9, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24480691

ABSTRACT

PURPOSE: To explore the incidence of failure of continuous peripheral nerve blockade (CPNB) after upper extremity operations. METHODS: Patient data regarding postoperative CPNB were retrospectively obtained from our institution's regional anesthesia database. Documented information on the first postoperative day included pain assessment ratings (numerical verbal pain scale, patient-reported breakthrough pain upon perceived return of sensation, appearance of the catheter site, complications, time of return of sensation, day of return of sensation, residual blockade, patient satisfaction with the block, and whether patient would receive the block again). RESULTS: A total of 207 patients received CPNB for postoperative analgesia. The failure rate on the first postoperative day for infraclavicular (133 patients) and supraclavicular (58 patients) CPNB was 19% and 26%, respectively. Interscalene CPNB (16 patients) yielded 3 incidences of failure. No significant difference was found between supraclavicular and infraclavicular block techniques. In addition, no significant differences were found between the incidences of CPNB failures with potentially more painful surgeries involving bone compared with potentially less painful soft tissue procedures. CONCLUSIONS: The CPNB technique used for hand surgery postoperative analgesia was associated with nontrivial failure rates. The potential of CPNB failure and resulting breakthrough pain upon recovery from the primary nerve block is important to help establish patient expectations. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.


Subject(s)
Amides , Arm/innervation , Arm/surgery , Bupivacaine , Catheters, Indwelling , Nerve Block/methods , Pain Measurement , Pain, Postoperative/prevention & control , Peripheral Nerves/drug effects , Peripheral Nerves/physiopathology , Adolescent , Adult , Aged , Aged, 80 and over , Breakthrough Pain/diagnosis , Child , Female , Humans , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Ropivacaine , Treatment Failure , Young Adult
9.
Pain Pract ; 14(8): 757-69, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24373184

ABSTRACT

A large percentage of patients with chronic pain on around-the-clock (ATC) opioids may experience increased pain occurring at the end of a scheduled dose, also known as end-of-dose pain. Despite the significant prevalence and impact of end-of-dose pain in patients using extended-release (ER) opioids, there are no detailed analyses examining how the frequency of end-of-dose pain is linked to the formulations of long-acting opioids. Consequently, we performed a systematic review to evaluate how many published studies on patients with chronic cancer or noncancer pain identified end-of-dose pain. As only a few studies mentioned end-of-dose pain explicitly, we used breakthrough pain (BTP) as a surrogate parameter. We determined if any opioid formulation had a greater association with the frequency of BTP, the use of rescue medication for BTP, and the frequency of end-of-dose pain. Of the 39 studies entered in the final analysis, 14 studies across different formulations showed that ER opioids were effective in the prevention of BTP. The opioids most frequently studied were hydromorphone (26%), followed by morphine (23%), and transdermal buprenorphine (23%). Only 5% of the studies used immediate-release preparations. Overall, most studies showed that patients using ER preparations experienced fewer episodes of BTP compared with patients on placebo or an active comparator. This could reflect the favorable duration of action of these opioids compared with short-acting formulations. Future studies should examine the incidence of end-of-dose pain and use of rescue medicine in a longitudinal manner in patients with chronic pain taking short- vs. long-acting ATC opioids.


Subject(s)
Analgesics, Opioid/administration & dosage , Analgesics, Opioid/therapeutic use , Breakthrough Pain/drug therapy , Chronic Pain/drug therapy , Breakthrough Pain/diagnosis , Chronic Pain/diagnosis , Humans , Pain Measurement/methods , Time , Treatment Outcome
11.
J Natl Compr Canc Netw ; 11 Suppl 1: S29-36, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23520183

ABSTRACT

The moral imperative to adequately manage pain is being increasingly recognized worldwide. A comprehensive pain management approach that addresses the various presentations of pain in patients with cancer is required, including appropriate management of breakthrough pain. Breakthrough pain commonly occurs in patients with advanced cancer and is disabling to the individual and burdensome to society, yet it is often inadequately managed. Because pain is heterogeneous, the best management of an individual's pain, including breakthrough pain in cancer, requires a thorough assessment to tailor the treatment strategies. Recently developed guidelines support this approach and recommend treating breakthrough pain using rapid- or short-acting opioids with pharmacodynamics that mirror the rapid onset and short duration of the presenting pain. This approach should be part of a comprehensive strategy to treat pain within the context of the primary disease trajectory, offering continuity of care and access to specialized palliative care when appropriate.


Subject(s)
Breakthrough Pain/therapy , Guidelines as Topic , Neoplasms/complications , Neoplasms/therapy , Pain Management/standards , Palliative Care , Breakthrough Pain/diagnosis , Breakthrough Pain/etiology , Humans , Pain Measurement
12.
Rev Med Suisse ; 9(392): 1360, 1362-5, 2013 Jun 26.
Article in French | MEDLINE | ID: mdl-23882913

ABSTRACT

Diagnostic or therapeutic procedures can lead to breakthrough pain. Thanks to a wise choice of analgesic medication started in due time, this type of pain can be avoided or decreased. The therapeutic options of this preventive approach are presented according to the expected breakthrough pain type and intensity. Specific situations are presented through case discussions. The main pharmacokinetic information needed to prescribe the right analgesic at the right time is summarized in a convenient table. When associated to non-pharmacological measures such as empathy, patient positioning and high quality procedures, preventive analgesia provides patients the best possible relief from breakthrough pain.


Subject(s)
Analgesics/therapeutic use , Bone Neoplasms/drug therapy , Breakthrough Pain/drug therapy , Carcinoma/drug therapy , Kidney Failure, Chronic/complications , Lung Neoplasms/drug therapy , Pleural Effusion/drug therapy , Administration, Cutaneous , Aged , Analgesics, Opioid/administration & dosage , Anesthetics, Local/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Bone Neoplasms/complications , Bone Neoplasms/secondary , Breakthrough Pain/diagnosis , Breakthrough Pain/etiology , Carcinoma/complications , Carcinoma/secondary , Drug Therapy, Combination , Empathy , Female , Humans , Lidocaine/administration & dosage , Lung Neoplasms/complications , Lung Neoplasms/pathology , Male , Middle Aged , Patient Positioning , Pleural Effusion/complications , Pleural Effusion/diagnosis , Pleural Effusion/surgery , Prilocaine/administration & dosage , Treatment Outcome
13.
PLoS One ; 18(7): e0286947, 2023.
Article in English | MEDLINE | ID: mdl-37428747

ABSTRACT

OBJECTIVE: Breakthrough cancer pain should be properly assessed for better-personalized treatment plan. The Breakthrough Pain Assessment Tool is a 14-item tool validated in English developed for this purpose; no French version is currently available and validated. This study aimed to translate it in French and assess the psychometric properties of a French version of the Breakthrough Pain Assessment Tool (BAT-FR). METHODS: First, translation and cross-cultural adaptation of the 14 items (9 ordinal and 5 nominal) of the original BAT tool in French language was made. Second, assessments of validity (convergent, divergent and discriminant validity), factorial structure (exploratory factor analysis) and test-retest reliability of the 9 ordinal items were done with data of 130 adult cancer patients suffering from breakthrough pain in a hospital-academic palliative care center. Test-retest reliability and responsiveness of total and dimension scores derived from these 9 items were also assessed. Acceptability of the 14 items was also assessed on the 130 patients. RESULTS: The 14 items had good content and face validity. Convergent and divergent validity, discriminant validity and test-retest reliability of the ordinal items were acceptable. Test-retest reliability and responsiveness of total and dimensions derived from ordinal items were also acceptable. The factorial structure of the ordinal items had two dimensions similar to the original version: "1-pain severity and impact" and "2-pain duration and medication". Items 2 and 8 had a low contribution to the dimension 1 they were assigned and item 14 clearly changed of dimension compared with the original tool. The acceptability of the 14 items was good. CONCLUSION: The BAT-FR has shown acceptable validity, reliability and responsiveness supporting its use for assessing breakthrough cancer pain in French-speaking populations. Its structure needs nevertheless further confirmation.


Subject(s)
Breakthrough Pain , Cancer Pain , Neoplasms , Adult , Humans , Reproducibility of Results , Breakthrough Pain/diagnosis , Cancer Pain/diagnosis , Surveys and Questionnaires , Language , Psychometrics/methods , Neoplasms/complications , Cross-Cultural Comparison
14.
BMJ Open ; 13(9): e073670, 2023 09 28.
Article in English | MEDLINE | ID: mdl-37770268

ABSTRACT

OBJECTIVE: This study examined knowledge and practice of breakthrough cancer pain (BTcP) management among general practitioners (GPs) providing palliative care in Shanghai. DESIGN: Cross-sectional study using a self-administered questionnaire. SETTING AND PARTICIPANTS: A total of 393 GPs providing palliative care in 32 community health service centres in Shanghai were recruited by stratified cluster random sampling between 1 May and 30 June 2022. OUTCOME MEASURES: Knowledge and practice concerning BTcP management. RESULTS: A total of 375 questionnaires were collected and declared valid. The median knowledge score was 11 out of 21 points. Only 36.3% (n=136) of the participating GPs scored 11 points or more, which was categorised as good knowledge. Only 24.8% (n=93) of the GPs used Davies' adapted diagnostic algorithm as the gold standard for diagnosis. All of the GPs assessed the intensity of BTcP; however, less than a quarter of the GPs evaluated the relationship between background pain and BTcP (22.1%, n=83), the impact of BTcP on activities of daily living (24.0%, n=90), the impact of BTcP on social relationships (14.4%, n=54) and the impact of BTcP on mood (10.1%, n=38). 56.5% (n=212) of the GPs reported that they used pain tools in the assessment of BTcP. All of the GPs prescribed immediate-release morphine as rescue medication for relieving BTcP; however, 60.5% (n=227) prescribed the dose based on their personal experiences, irrespective of the basal opioid dose, and 57.3% (n=215) did not conduct dose titration after providing the initial dose. No GPs reported that they ever administered interventional treatment to their patients. CONCLUSIONS: Insufficient knowledge and inappropriate behaviours in BTcP diagnosis, assessment and treatment were identified. There is an urgent need to improve BTcP management among GPs providing palliative care in Shanghai.


Subject(s)
Breakthrough Pain , Cancer Pain , General Practitioners , Neoplasms , Humans , Palliative Care , Cross-Sectional Studies , Cancer Pain/diagnosis , Cancer Pain/drug therapy , Activities of Daily Living , Neoplasms/complications , Neoplasms/drug therapy , China , Analgesics, Opioid/therapeutic use , Breakthrough Pain/diagnosis , Breakthrough Pain/drug therapy
15.
Int J Clin Pharmacol Ther ; 50(9): 665-77, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22784611

ABSTRACT

BACKGROUND: The development of intranasal fentanyl (INFS) aimed for a rapid treatment of breakthrough pain (BTP) in cancer patients. The pharmacokinetics (PK) of INFS was well characterized in healthy subjects, while PK investigations in cancer patients are limited. OBJECTIVES: The objective was to develop a population PK model for fentanyl in volunteers and patients following INFS administration, to evaluate the influence of potential covariates and to simulate the exposure of fentanyl after repeated dosing in cancer patients. METHODS: PK data from ten clinical trials were used for model development. The final model was validated with nonparametric bootstrap and visual predictive check. In addition, the secondary PK parameters (AUC0-tlast, Cmax, tmax) of a separate validation data set of INFS were predicted and compared to noncompartmental analysis results. Afterwards, repeated dose PK profiles in cancer patients were simulated. RESULTS: Plasma profiles after INFS administration were best described by a three-compartment model. Significant covariate relationships were identified for naltrexone and oxymetazoline co-treatment. Influences of body weight, BMI, sex and cancer patient as subject type were considered not to be clinically relevant. PK parameters for subpopulations of cancer patients were derived. Steady state simulations revealed that an extension from the current SmPC scenario to 6 pain episodes per day would yield similar Cmax values. CONCLUSIONS: A robust population PK model for INFS was developed. The model enhances the understanding of fentanyl PK after INFS dosing in cancer patients with BTP, a population for whom real-life data would be very hard to obtain.


Subject(s)
Analgesics, Opioid/administration & dosage , Analgesics, Opioid/pharmacokinetics , Breakthrough Pain/drug therapy , Fentanyl/administration & dosage , Fentanyl/pharmacokinetics , Models, Biological , Neoplasms/complications , Administration, Intranasal , Aerosols , Analgesics, Opioid/blood , Area Under Curve , Breakthrough Pain/diagnosis , Breakthrough Pain/etiology , Computer Simulation , Fentanyl/blood , Humans , Metabolic Clearance Rate , Reproducibility of Results , Treatment Outcome
16.
Clin J Oncol Nurs ; 26(5): 559-563, 2022 09 15.
Article in English | MEDLINE | ID: mdl-36108211

ABSTRACT

Breakthrough cancer pain (BCP) is a devastating symptom that can occur in individuals with cancer throughout the disease trajectory, particularly in those with advanced cancer. Oncology nurses have a critical role in treating.


Subject(s)
Breakthrough Pain , Cancer Pain , Neoplasms , Breakthrough Pain/diagnosis , Breakthrough Pain/drug therapy , Cancer Pain/therapy , Humans , Neoplasms/complications , Oncology Nursing , Outpatients
17.
Scand J Pain ; 21(4): 688-695, 2021 10 26.
Article in English | MEDLINE | ID: mdl-33930265

ABSTRACT

OBJECTIVES: Breakthrough cancer pain (BTcP) is a transient exacerbation of pain that occurs over persistent, stable, and adequately controlled cancer background pain. It is prevalent and bears severe consequences to patients' quality-of-life. The effective management of BTcP depends on fast and reliable (re)assessment. The Breakthrough pain Assessment Tool (BAT) is one of the most concise and reliable self-report instruments adapted to clinical contexts so far, showing good psychometric qualities in the United Kingdom, the Netherlands, and South Korea. As to promote the effective management of BTcP in Portuguese-speaking communities this study, first aimed to culturally adapt and validate the Portuguese version of the BAT (BAT-Pt). Second, and most importantly, it sought to provide novel evidence on its criterion validity by investigating its association with measures of psychological distress, which has not been yet investigated. METHODS: The BAT was translated into European Portuguese, using the back-translation method, and culturally adapted. Its psychometric properties (factor structure, internal consistency, construct and criterion validity) were analyzed in a cross-sectional multicenter study, with a sample of 65 cancer patients (49.2% women) recruited from eight hospitals in mainland Portugal (a priori power analysis determined a minimum sample of 50). Health professionals collected patients' clinical information, assessed their functional disability (ECOG Performance Status) and the adequacy of pain control. In addition to the Portuguese version of the BAT (BAT_Pt), patients completed the Portuguese versions of the Brief Pain Inventory, the Hospital Anxiety and Depression Scale, a Distress Thermometer and answered questions about the adequacy of pain control. RESULTS: The BAT-Pt was very well accepted by experts and patients. As hypothesized, a Principal Axis Factor Analysis revealed two underlying factors accounting for 55.2% of the variance: (1) Pain Severity and Impact of BTcP and (2) Duration of BTcP and Medication Inefficacy. Two items (on episode frequency and medication efficacy) were analyzed separately given their lower/cross loadings. The BAT-Pt showed good internal consistency overall (α=0.79) and for each sub-scale, namely, Pain Severity and Impact of BTcP (n=5 items; α=0.86) and Duration of BTcP and Medication Inefficacy (n=2 items; rsb=0.62). The BAT-Pt showed good convergent validity, being moderately to strongly associated with overall pain severity and interference (0.46

Subject(s)
Breakthrough Pain , Neoplasms , Breakthrough Pain/diagnosis , Cross-Sectional Studies , Female , Humans , Male , Neoplasms/complications , Portugal , Psychometrics , Reproducibility of Results , Surveys and Questionnaires
18.
BMJ Open ; 10(3): e035541, 2020 03 29.
Article in English | MEDLINE | ID: mdl-32229524

ABSTRACT

INTRODUCTION: Breakthrough pain is common in children and adults with cancer and other conditions, including those approaching end-of-life, although it is often poorly managed, possibly partly due to a lack of validated assessment tools. This review aims to (1) identify all available instruments measuring breakthrough pain in infants, children, adolescents or adults and (2) critically appraise, compare and summarise the quality of the psychometric properties of the identified instruments using COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. METHODS AND ANALYSIS: Two searches will be carried out between October 2019 and January 2020, one for each aim of the review. The Cochrane Library, International Prospective Register of Systematic Reviews, Embase, Cumulative Index of Nursing and Allied Health Literature, Medical Literature Analysis and Retrieval System Online (MEDLINE), PsycINFO, Web of Science Core Collection, Google Scholar, the ProQuest Dissertations & Theses Database, Evidence Search and OpenGrey databases will be searched from database inception until the date the search is conducted. Reference lists of eligible articles will be screened and authors in the field contacted. For search 1, articles will be screened by two reviewers by abstract, and full-text where necessary, to identify if a breakthrough pain assessment was used. Search 2 will then be conducted to identify studies evaluating measurement properties of these assessments. Two reviewers will screen articles from search 2 by title and abstract. All potentially relevant studies will be screened by full text by both reviewers. For search 2, data will be extracted in parallel with the quality assessment process, as recommended by COSMIN. Two reviewers will assess methodological quality using the COSMIN Risk of Bias checklist and the COSMIN updated criteria for good measurement properties. Findings will be summarised and, if possible, data will be pooled using meta-analysis. The quality of the evidence will be graded and summarised using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) guidelines. ETHICS AND DISSEMINATION: Results of this review will be submitted for publication in a peer review journal and presented at conferences. PROSPERO REGISTRATION NUMBER: CRD42019155583.


Subject(s)
Breakthrough Pain , Psychometrics , Breakthrough Pain/diagnosis , Breakthrough Pain/psychology , Breakthrough Pain/therapy , Humans , Meta-Analysis as Topic , Pain Management , Systematic Reviews as Topic
19.
J Pain Symptom Manage ; 59(3): 709-716.e2, 2020 03.
Article in English | MEDLINE | ID: mdl-31877346

ABSTRACT

CONTEXT: Essential for adequate management of breakthrough cancer pain is a combination of accurate (re-)assessment and a personalized treatment plan. The Breakthrough Pain Assessment Tool (BAT) has been proven to be a brief, multidimensional, reliable, and valid questionnaire for the assessment of breakthrough cancer pain. OBJECTIVES: The aim of this study was to examine the validity and reliability of the Dutch Language version of the BAT (BAT-DL) in patients with cancer. METHODS: The BAT was forward-backward translated into the Dutch language. Thereafter, the psychometric properties of the BAT-DL were tested, that is factor structure, reliability (internal consistency and test-retest reliability), validity (content validity and construct validity), and the responsiveness to change. RESULTS: The BAT-DL confirmed the two-factor structure in 170 patients with cancer: pain severity/impact factor and pain duration/medication efficacy factor. The Cronbach's alpha coefficient was 0.72, and the intraclass correlation for the test-retest reliability was 0.81. The BAT-DL showed to be able to differentiate between different group of patients and correlated significantly with the Brief Pain Inventory. In addition, the BAT-DL was capable to detect clinically important changes over time. CONCLUSION: The BAT-DL is a valid and reliable questionnaire to assess breakthrough pain in Dutch patients with cancer and is a relevant questionnaire for daily practice.


Subject(s)
Breakthrough Pain , Neoplasms , Breakthrough Pain/diagnosis , Breakthrough Pain/drug therapy , Humans , Language , Neoplasms/complications , Neoplasms/diagnosis , Pain Measurement , Psychometrics , Reproducibility of Results , Surveys and Questionnaires
20.
Clin Transl Oncol ; 22(8): 1216-1226, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32002739

ABSTRACT

In this paper, we review the current state of breakthrough cancer pain (BTcP) management. BTcP is a heterogeneous condition and a global problem for cancer patients. It is often managed suboptimally, which results in a negative outcome for patients, healthcare providers, and healthcare systems. Several barriers to the appropriate management of BTcP have been identified. These include, among others, an incomplete definition of BTcP, poor training of healthcare providers and patients alike, a lack of a multidisciplinary approach and the absence of specific protocols and tools. We provide some actions to help physicians and patients improve their approach to BTcP, including specific training, the design of easy-to-use tools for BTcP identification and assessment (such as checklists and pocket-sized cards), individualized treatment, and the use of multidisciplinary teams.


Subject(s)
Analgesics, Opioid/administration & dosage , Breakthrough Pain/drug therapy , Cancer Pain/drug therapy , Fentanyl/administration & dosage , Pain Management/methods , Algorithms , Breakthrough Pain/diagnosis , Breakthrough Pain/etiology , Cancer Pain/diagnosis , Cancer Pain/etiology , Communication , Humans , Oncologists/education , Pain Management/psychology , Pain Measurement/methods , Physician-Patient Relations , Practice Guidelines as Topic
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