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IMPORTANCE: Studies have demonstrated the benefits of INF in reducing pain scores in pediatric patients with VOC due to sickle cell disease (SCD) and in adult patients with chronic pain conditions other than VOC, such as cancer. However, there is limited literature that exists describing the role of INF in adult patients with VOC due to SCD. Current literature demonstrates that the use of IV morphine for VOC patients leads to reduced pain. Therefore, comparing the use of INF with IV morphine will establish the degree of effectiveness of INF for VOC patients. OBJECTIVE: To determine if intranasal fentanyl is equally as effective as IV morphine for treating VOC-associated pain in adult SCD patients. DESIGN: This study was a retrospective non-inferiority cohort study. Electronic health records were utilized to identify eligible patients between January 1, 2021 to February 28, 2022. Patients who received INF as an initial opioid upon presentation to the ED where allocated to the intervention group. On the other hand, individuals who received IV morphine as an initial opioid upon presentation to the ED were allocated to the control group. SETTING: A multi-site healthcare system containing five hospitals. PARTICIPANTS: Patients 18 years of age or older, admitted to the ED with VOC due to SCD, and received INF or IV morphine as an initial opioid upon presentation to the ED. MAIN OUTCOMES AND MEASURES: The primary outcome was to evaluate the percent change in pain reduction after the initial dose of opiate between groups. Secondary outcomes include time to first rescue medication, total morphine milligram equivalent (MME) of IV opiates, hypotension, bradycardia, respiratory distress requiring opiate reversal within 6 h post- study drug administration, readmission within 48 h, and ED disposition. RESULTS: A total of 230 patients were reviewed within the study period, 95 subjects met inclusion criteria, 31 subjects were included in the INF arm and 64 subjects in the IV morphine arm. The primary outcome showed an average percent pain reduction of 17.25% in the INF arm and 17.15% in the IV morphine arm. The point estimate difference was 0.1% (95% CI -9.3%-9.5%; non-inferiority (p < 0.0001). The median dose of IV opiates was 8 MME in the INF group, and 6 MME in the IV morphine group (p = 0.0268). The time from study drug to first rescue medication administration was 22.4 min and 27.3 min in the INF and IV morphine groups, respectively (p = 0.2231). There was no incidence of hypotension or respiratory distress requiring opiate reversal in either arm. Bradycardia occurred in 12.9% and 7.7% (p = 0.2042), readmission rates within 48 h due to VOC was 6.5% and 20.9% (p = 0.0553), and discharge from the ED to home was 16% and 66% (p = 0.0196) in INF and IV morphine arms, respectively. CONCLUSION: INF provided similar pain reduction compared to IV morphine in the treatment of adults with VOC presenting to the ED. IV morphine arm showed a statistically significant difference in discharge to home from the ED, however there was a trend in readmission within 48 h. The study showed no significant difference in hypotension, respiratory distress, or bradycardia between the groups. The INF group had no significant impact on time to drug administration compared to IV morphine, however it was within 1 h of patient presentation which complies with American Society of Hematology (ASH) guidelines. In conclusion, our study showed that INF was non-inferior when compared to IV morphine in reducing pain scores after drug administration. Therefore, INF is an effective alternative to IV morphine for pain management in adults presenting to the ED for VOC particularly in those with limited IV access.
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Anemia de Células Falciformes , Hipotensión , Alcaloides Opiáceos , Síndrome de Dificultad Respiratoria , Adolescente , Adulto , Niño , Humanos , Administración Intranasal , Analgésicos Opioides/uso terapéutico , Anemia de Células Falciformes/complicaciones , Bradicardia/tratamiento farmacológico , Estudios de Cohortes , Fentanilo/uso terapéutico , Hipotensión/tratamiento farmacológico , Morfina/uso terapéutico , Alcaloides Opiáceos/uso terapéutico , Dolor/etiología , Dolor/complicaciones , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , Estudios RetrospectivosRESUMEN
BACKGROUND: Pain management guidelines in the emergency department (ED) may reduce time to analgesia administration (TTA). Intranasal fentanyl (INF) is a safe and effective alternative to intravenous opiates. The effect of an ED pain management guideline providing standing orders for nurse-initiated administration of intranasal fentanyl (INF) is not known. The objective of this study was to determine the impact of a pediatric ED triage-based pain protocol utilizing intranasal fentanyl (INF) on time to analgesia administration (TTA) and patient and parent satisfaction. METHODS: This was a prospective study of patients 3-17â¯years with an isolated orthopedic injury presenting to a pediatric ED before and after instituting a triage-based pain guideline allowing for administration of INF by triage nurses. Our primary outcome was median TTA and secondary outcomes included the proportion of patients who received INF for pain, had unnecessary IV placement, and patient and parent satisfaction. RESULTS: We enrolled 132 patients; 72 pre-guideline, 60 post-guideline. Demographics were similar between groups. Median TTA was not different between groups (34.5â¯min vs. 33â¯min, pâ¯=â¯.7). Utilization of INF increased from 41% pre-guideline to 60% post-guideline (pâ¯=â¯.01) and unnecessary IV placement decreased from 24% to 0% (pâ¯=â¯.002). Patients and parents preferred the IN route for analgesia administration. CONCLUSION: A triage-based pain protocol utilizing INF did not reduce TTA, but did result in increased INF use, decreased unnecessary IV placement, and was preferred by patients and parents to IV medication. INF is a viable analgesia alternative for children with isolated extremity injuries.
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Analgésicos Opioides/administración & dosificación , Fentanilo/administración & dosificación , Dolor/prevención & control , Administración Intranasal , Adolescente , Niño , Preescolar , Femenino , Adhesión a Directriz , Humanos , Masculino , Dimensión del Dolor , Guías de Práctica Clínica como Asunto , Estudios Prospectivos , Autoinforme , Centros de Atención Terciaria , Atención Terciaria de Salud , Resultado del Tratamiento , Triaje/métodosRESUMEN
BACKGROUND: Analgesia administration for children with vaso-occlusive crises is often delayed in the emergency department. Intranasal fentanyl (INF) has been shown to be safe and effective in providing rapid analgesia for other painful conditions. Our objective was to determine if children with a vaso-occlusive crisis (VOC) who received initial treatment with INF compared to placebo achieved a greater decrease in pain score after 20 min. PROCEDURE: This was a randomized, double-blind, placebo-controlled trial. Children with sickle cell disease, 3-20 years old, not taking daily opiates were eligible for the study. Subjects who presented to the emergency department with a pain score ≥6 were randomized to either a single dose of INF (2 µg/kg, maximum 100 µg) or an equivalent volume of intranasal saline. Pain scores were obtained using a modified Wong-Baker FACES pain scale prior to the administration of study drug and at 10, 20, and 30 min afterward. Additional analgesic medication was given per standard protocol. RESULTS: Forty-nine subjects completed the study (24 fentanyl and 25 placebo). Subjects who received INF had a greater decrease in median pain score at 20 min compared to placebo (2 [interquartile range, (IQR) 0.5-4] vs. 1 [IQR 0-2], P = 0.048), but not at 10 or 30 min. There were no serious adverse events in either group. CONCLUSION: Children who received INF had a greater decrease in pain score at 20 min compared to those who received placebo. Further studies should evaluate how to best incorporate INF into the emergency care of a child with a VOC.
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Anemia de Células Falciformes/tratamiento farmacológico , Fentanilo/administración & dosificación , Enfermedades Vasculares/tratamiento farmacológico , Administración Intranasal , Adolescente , Adulto , Anemia de Células Falciformes/complicaciones , Anemia de Células Falciformes/fisiopatología , Niño , Preescolar , Femenino , Humanos , Masculino , Factores de Tiempo , Enfermedades Vasculares/etiología , Enfermedades Vasculares/fisiopatologíaRESUMEN
BACKGROUND: Breakthrough cancer pain (BTCP) is complex and severe, affecting quality of life and increasing hospitalisation. BTCP has a rapid onset that requires fast acting medication with minimal side effects. AIM: This article compares the effectiveness of intranasal fentanyl spray (INFS) and oral transmucosal fentanyl citrate (OTFC) and their alleviation of BTCP within 10 minutes of administration. METHOD: The article considers pharmacokinetic and bioavailability studies demonstrating the efficacy of the route of administration, time-based effects of pain relief as well as patient preference. CONCLUSION: The data collected indicates that INFS is more effective than OTFC for BTCP.
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Objectives: Sedation and stability during electroencephalography (EEG) in pediatrics have high clinical importance. This study compares the sedative properties of oral chloral hydrate (OCH) and intranasal fentanyl (INF). Materials & Methods: This study was a randomized clinical trial conducted in 2020 in Isfahan City on sixty-two pediatric candidates for EEG. Patients were randomized into two groups receiving 50 mg/kg OCH and 2 µg/kg INF thirty minutes before the process. The heart rate (HR), mean arterial pressure (MAP), respiratory rate (RR), and oxygen saturation (O2 sat) of patients, sedation, and physician's satisfaction were measured and compared between groups. Results: The HR of patients decreased significantly in both groups (P< 0.001), and the patients that received INF had significantly lower HR 15, 30, 45, and 60 minutes after drug administrations (P< 0.05). RR evaluation indicated significantly decreased RR in both groups (P< 0.001), and patients receiving INF had lower RR 30, 45, and 60 per minutes after drug administrations (P< 0.001). Both groups showed significantly increased sedation levels during the study (P< 0.001), and patients treated with INF had higher sedation levels 15, 30, and 45 minutes after drug administration. Satisfaction rates were higher among the group that received INF (P= 0.020). Conclusion: The use of INF had significant analgesic and sedative effects on pediatrics undergoing EEG.
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Background: Nurse-directed pain protocols for intranasal fentanyl administration are not widely implemented in European (EU) pediatric emergency departments (PED). Barriers include perceived safety concerns for intranasal (IN) fentanyl. The aim of this study is to describe our experience with a nurse-directed triage IN fentanyl protocol with a focus on safety in a tertiary EU PED. Methods: We conducted a retrospective analysis of patient records of children aged 0-16 years who received nurse-directed IN fentanyl between January 2019 and December 2021 at the PED of the University Children's Hospital of Bern, Switzerland. Extracted data points included demographics, presenting complaint, pain score, IN fentanyl dosage, concomitant pain medication use, and adverse events. Results: A total of 314 patients were identified with ages ranging from 9 months to 15 years. The main indication for nurse-directed fentanyl administration was musculoskeletal pain due to trauma (n = 284, 90%). Mild adverse events (vertigo) were reported in two patients (0.6%), without a correlation to concomitant pain medication or protocol violation. The only reported severe adverse event of syncope and hypoxia in a 14-year-old adolescent occurred in a setting where the institutional nurse-directed protocol was violated. Conclusion: In accordance with previous studies outside of Europe, our data support the case that when appropriately used, nurse-directed IN fentanyl is a safe potent opioid analgesic for pediatric acute pain management. We strongly encourage the introduction of nurse-directed triage fentanyl protocols Europe-wide in order to provide effective and adequate acute pain management in children.
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OBJECTIVES: We aimed to assess the tolerance of fentanyl pectin nasal spray (FPNS) when used to treat procedural pain caused by wound dressing or physiotherapy in patients older than 75 years with or without opioid background treatment. DESIGN: This is a prospective monocentric, noncontrolled, nonrandomized study conducted from December 2014 to October 2017 in 2 geriatric wards (rehabilitation and acute medicine). SETTING AND PARTICIPANTS: Fifty-seven patients were included and 314 procedures were monitored. METHODS: For each patient, 6 procedures were monitored: the first 2 without specific treatment, then fentanyl was started at 100 µg with a titration over a few procedures up to 800 µg in non-opioid-naïve patients and 400 µg in opioid-naïve. Sedation and respiratory scale were monitored during the procedures. All adverse drug events occurring from inclusion to 5 days after the intervention were collected and their imputability was assessed separately by 2 pharmacovigilance experts. RESULTS: Overall, 14.4% of the sessions with FPNS administration resulted in adverse drug events. Main adverse drug events were nausea and vomiting, somnolence, and confusion. Most of them were of mild to moderate severity. Four severe adverse events were due to accidental overdoses. No unexpected adverse event occurred. Tolerance was similar for opioid-naïve and non-opioid-naïve patients (P value = .93). CONCLUSION AND IMPLICATIONS: FPNS was overall well tolerated in geriatric patients. Given its interesting pharmacokinetics, fentanyl is a promising lead for procedural pain treatment in geriatric patients, even those who are opioid naïve.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Neoplasias , Dolor Asociado a Procedimientos Médicos , Anciano , Analgésicos Opioides , Fentanilo , Humanos , Rociadores Nasales , Dolor Asociado a Procedimientos Médicos/inducido químicamente , Pectinas/efectos adversos , Pectinas/farmacocinética , Estudios ProspectivosRESUMEN
OBJECTIVE: The risk of inappropriate use of opioid drugs increases, especially the short-acting ones. The risk of addiction in patients with cancer with a relatively good prognosis is a challenge. The aim of the study is to evaluate the decision to continue therapy with a short-acting fentanyl. METHODS: The study concerns a 49-year-old male patient with an advanced neuroendocrine tumour in the pre-sacral region. The research method includes the medical history and physical examination, an analysis of the patient's medical record and a self-designed questionnaire to assess the degree of dependence on opioid drugs. RESULTS: The analysis of the results of the survey confirmed the patient's dependence on opioid drugs. He gave positive answers to 16 out of 19 questions in the survey. CONCLUSION: Despite an addiction, the improvement of life quality is of the utmost importance. Therefore, decision to continue the intranasal fentanyl therapy is justified because of toleration and a high satisfactory effect.
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Fentanilo , Neoplasias , Administración Intranasal , Analgésicos Opioides/uso terapéutico , Fentanilo/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/tratamiento farmacológico , Calidad de VidaRESUMEN
OBJECTIVES: We report a case series of one-time 4 mcg/kg dose of intranasal dexmedetomidine and 1 mcg/kg of intranasal fentanyl plus inhaled nitrous oxide for procedural sedation in children with otitis media with effusion (OME) for tympanostomy tube placement with a specific handheld device (Solo TTD, AventaMed ®). METHODS: A retrospective review was conducted in a tertiary paediatric teaching hospital on patients with OME referred from December 2018 to December 2019 in need of procedural sedation for myringotomy and ventilation tube insertion (VTI). Sixteen of twenty-four consecutively admitted subjects received a one-time dose (4 mcg/kg) of intranasal dexmedetomidine and 1mcg/Kg of intranasal fentanyl followed by inhaled nitrous oxide (iN2O) at 50% with the intended goal to achieve a Ramsay Sedation Score 4 allowing a motionless procedure with adequate analgesia. Parents' satisfaction for the procedure was measured by mean of a Likert scale (from 0 to 5 points). RESULTS: Sixteen patients underwent procedural sedation for myringotomy with VTI. Sedation was achieved successfully in fifteen patients (93,75%), with a mean induction time of 29 min (range 19-43) and a mean recovery time of 74 min (range 54-110). The patient who did reach an adequate sedation level underwent an intravenous line positioning and a dose of ketamine. No adverse effects were reported, and the parents' judgment average on the Likert scale was 4,93. VTI procedure was successful in all ears. CONCLUSIONS: A combination of intranasal dexmedetomidine, fentanyl, and iN2O could be considered as a possible option for procedural sedation in children with OME undergoing procedural sedation for tympanostomy tube placement in children with Solo TTD device.
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Analgésicos Opioides/administración & dosificación , Dexmedetomidina/administración & dosificación , Fentanilo/administración & dosificación , Hipnóticos y Sedantes/administración & dosificación , Ventilación del Oído Medio , Óxido Nitroso/administración & dosificación , Administración Intranasal , Anestesia , Anestésicos por Inhalación/administración & dosificación , Niño , Preescolar , Quimioterapia Combinada , Femenino , Humanos , Ketamina/administración & dosificación , Masculino , Manejo del Dolor , Estudios RetrospectivosRESUMEN
Breakthrough cancer pain (BTcP) is a common condition in oncological patients. However, its management is still suboptimal. Improved knowledge of BTcP and its management in clinical practice may have immediate importance for all physicians involved in the supportive care of cancer patients. This review critically discusses the most important concepts for the correct diagnosis of BTcP and presents some intriguing cases of the management of this condition in clinical practice. Overall, the most appropriate therapeutic choice appears to be a rapid-onset opioid (ROO), and in particular, the nasal route of administration is the quickest and most convenient mode of administration for the management of BTcP, especially when the patient needs rapid resolution of pain. To this end, intranasal fentanyl spray may have a particular relevance in clinical practice. Future research should focus on accepted definitions of BTcP to investigate the optimal management of this highly heterogeneous pain condition. Therapeutic decision-making of patients, clinicians, and payers will likely be driven from results of well-designed clinical trials of ROOs.
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INTRODUCTION: Intranasal fentanyl provides rapid and powerful analgesia which is particularly interesting in patients without intravenous access. We propose to use it for analgesia in adults presenting renal colics. METHODS: A prospective study was conducted from the 2nd January to February 2013 in our emergency department. Patients aged up to 18 years old who presented with renal colic were included in this audit. Patients were excluded if they had loss of consciousness, cognitive impairment, acute or chronic nasal problems. A formal written consent was obtained from patients. The research team was alerted by medical and nursing staff. A member of the research team would check with medical or nursing staff whether administration of Intra nasal (IN) fentanyl was required. It was administered at a pre-calculated dose of 1.5 mg/kg and 50 mg/ml concentration was used. Data was prospectively collected by one of the researchers at various intervals during the patient's presentation and recorded on a pre-formatted data sheet. Pain scores were collected at 5, 15, 30, 45 and 60 minutes following IN fentanyl using a visual analogue scale pain. Observations routinely collected for patients receiving IV opiates and any adverse events were also recorded. RESULTS: 23 eligible patients were enrolled; median age was 51,3 years. 47,8% were women and the mean weight was 73 kg. Median dose of IN fentanyl was 106 µg. Two patients have required morphinic analgesia despite having received adapted dose of IN fentanyl. The initial pain scores before IN fentanyl were high with a median of 82,2 mm (59-100). Five minutes after IN fentanyl administration the median pain score dropped to 48 mm(36-63) and achieved the lowest score of 8mm(0-22) at 30 min. Pain scores were significantly lower at 5 min (P < 0.001) and at all subsequent time points (P < 0.001). No side effects were recorded. CONCLUSION: Intranasal fentanyl seems to be efficient for analgesia in adult patients with renal colic.
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Analgésicos Opioides/administración & dosificación , Fentanilo/administración & dosificación , Dolor/tratamiento farmacológico , Cólico Renal/tratamiento farmacológico , Administración Intranasal , Adulto , Anciano , Analgésicos Opioides/uso terapéutico , Relación Dosis-Respuesta a Droga , Servicio de Urgencia en Hospital , Femenino , Fentanilo/uso terapéutico , Humanos , Masculino , Persona de Mediana Edad , Dolor/etiología , Dimensión del Dolor , Estudios ProspectivosRESUMEN
PURPOSE: The aims of this study were to explore the efficacy of intranasal fentanyl spray* (INFS) 400 µg to evaluate 12-week tolerability of the nasal mucosa and to explore safety data for all dose strengths of INFS in patients with cancer-related breakthrough pain (BTP). METHODS: Patients received a test dose of INFS 50 µg, followed by a titration phase. Those patients with doses titrated to 200 or 400 µg entered a randomized, double-blind, cross-over efficacy phase, in which 8 episodes of BTP were randomly treated with INFS 400 µg (6 episodes) and placebo (2 episodes), followed by a tolerability phase. Patients with doses titrated to 50 or 100 µg entered the tolerability phase directly. Primary outcome was measured by pain intensity difference at 10 minutes, analyzed using ANCOVA, and presented as least square mean difference. Examination of the nasal cavity was conducted at inclusion and after 12 weeks of treatment by an otorhinolaryngologist. FINDINGS: Forty-six patients were included. Thirty-eight patients' doses were titrated to an effective dose of INFS; 50 µg (n = 8), 100 µg (n = 9), 200 µg (n = 9), and 400 µg (n = 12); 15 patients entered the efficacy phase and 31 entered the tolerability phase. In the efficacy phase, 88 and 29 episodes of BTP were treated with INFS 400 µg and placebo, respectively. Pain intensity difference at 10 minutes least square mean for INFS 400 µg was 2.5 (95% CI, 1.42-3.49) (P < 0.001) and least square mean difference between INFS 400 µg and placebo was 1.1 (95% CI, 0.41-1.79) (P = 0.002). Runny nose (10%) and change in color of the mucosa (9%) were the most frequent findings of nasal examination, and nausea and dizziness were the most frequent treatment-related adverse events. One serious adverse event (ie, respiratory depression) was considered related to INFS. IMPLICATIONS: INFS 400 µg is effective and nasal tolerability and overall safety profile is acceptable during 12 weeks of use. ClinicalTrials.gov identifier: NCT01429051.
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Analgésicos Opioides/administración & dosificación , Dolor Irruptivo/tratamiento farmacológico , Fentanilo/administración & dosificación , Neoplasias/tratamiento farmacológico , Adulto , Anciano , Analgésicos Opioides/efectos adversos , Estudios Cruzados , Método Doble Ciego , Femenino , Fentanilo/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Náusea/inducido químicamente , Dimensión del DolorRESUMEN
PURPOSE: Despite the brevity of the procedure, bilateral myringotomy and tympanostomy tube placement (BMT) can result in significant postoperative pain and discomfort. As the procedure is frequently performed without intravenous access, non-parenteral routes of administration are frequently used for analgesia. The current study prospectively compares the efficacy of intranasal (IN) dexmedetomidine with IN fentanyl for children undergoing BMT. METHODS: This prospective, double-blinded, randomized clinical trial included pediatric patients undergoing BMT. The patients were randomized to receive either IN dexmedetomidine (1 µg/kg) or fentanyl (2 µg/kg) after the induction of general anesthesia with sevoflurane. All patients received rectal acetaminophen (40 mg/kg) and the first 50 patients also received premedication with oral midazolam. Postoperative pain and recovery were assessed using pediatric pain and recovery scales, and any adverse effects were monitored for. RESULTS: The study cohort included 100 patients who ranged in age from 1 to 7.7 years and in weight from 8.6 to 37.4 kg. They were divided into 4 groups with 25 patients in each group: (1) midazolam premedication+IN dexmedetomidine; (2) midazolam premedication+IN fentanyl; (3) no premedication+IN dexmedetomidine; and (4) no premedication+IN fentanyl. Pain scores were comparable when comparing groups 2, 3 and 4, but were higher in group 1 (midazolam premedication with IN dexmedetomidine). There was no difference in total time in the post-anesthesia care unit (PACU) or time from arrival in the PACU until hospital discharge between the 4 groups. The heart rate (HR) was significantly lower in group 3 when compared to the other groups at several different times after arrival to the PACU. No clinically significant difference was noted in blood pressure. CONCLUSION: Following BMT, when no premedication is administered, there was no clinical advantage when comparing IN dexmedetomidine (1 µg/kg) to IN fentanyl (2 µg/kg). The addition of oral midazolam as a premedication worsened the outcome measures particularly for children receiving IN dexmedetomidine.
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Dexmedetomidina/uso terapéutico , Fentanilo/uso terapéutico , Ventilación del Oído Medio , Dolor Postoperatorio/prevención & control , Membrana Timpánica/cirugía , Administración Intranasal , Analgésicos no Narcóticos/uso terapéutico , Analgésicos Opioides/uso terapéutico , Niño , Preescolar , Método Doble Ciego , Femenino , Frecuencia Cardíaca , Humanos , Hipnóticos y Sedantes/uso terapéutico , Lactante , Masculino , Midazolam/uso terapéutico , Dimensión del Dolor , Premedicación , Estudios ProspectivosRESUMEN
UNLABELLED: The aim of this randomized, crossover, comparison study was to assess the analgesic and adverse effects of 2 nasal preparations, intranasal fentanyl (INFS) and fentanyl pectin nasal spray (FPNS), for breakthrough pain, given in doses proportional to opioid basal regimen. Each patient randomly received INFS or FPNS in doses proportional to opioid dosages used for background analgesia for 2 pairs of episodes. For each episode of breakthrough pain, pain intensity and adverse effects intensity were recorded just before starting the INFS or FPNS (T0) and 5 minutes (T5), 10 minutes (T10), and 20 minutes (T20) after the administration of the nasal drugs. Sixty-nine patients were studied. The mean age was 63.4 years, and 37 patients were males. For the present analysis, 188 episodes were considered. A statistical decrease in pain intensity was observed with both nasal drugs after 5, 10, and 20 minutes. A decrease in pain intensity of >33% was observed in 16, 102, and 159 treated episodes at T5, T10, and T20, respectively. Adverse effects were of mild nature in most cases or were preexistent because of basal opioid therapy. No differences were found in summed pain intensity difference 20 minutes after dosing. Most of patients did not find substantial preferences. INFS and FPNS were effective and well-tolerated treatments for breakthrough pain management. Both delivery systems, in doses proportional to the basal opioid regimen, provided significant analgesia within 10 minutes, without producing relevant adverse effects. PERSPECTIVE: This article showed that INFS and FPNS in doses proportional to basal opioid regimen are equally safe and effective for the management of breakthrough pain in cancer patients. These data provide new insights on the use of nasal preparations of fentanyl.
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Analgésicos Opioides/administración & dosificación , Dolor Irruptivo/tratamiento farmacológico , Dolor Irruptivo/etiología , Fentanilo/administración & dosificación , Neoplasias/complicaciones , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Persona de Mediana Edad , Rociadores Nasales , Dimensión del Dolor , Pectinas/administración & dosificaciónRESUMEN
Introducción: La cirugía video laparoscópica posee beneficios para los pacientes. Las intervenciones con tiempos reducidos implican técnicas anestésicas ajustadas a ellos, lo que determina no pocas dificultades cuando el dolor aparece en la práctica asistencial. El hallazgo de pacientes con dolor posoperatorio inmediato motivó la realización del estudio. Objetivo: Evaluar la efectividad de un opioide de acción rápida como analgésico posoperatorio inmediato administrado vía intranasal. Método: Se desarrolló un estudio causiexpereimental, con dos grupos de enfermos (100 cada uno) a los que se les realizó colecistectomía por vía laparoscópica en el Hospital Militar Central Dr. Luis Díaz Soto, a los 100 pacientes en estudio se les administró FENTANYL 50 mcg intranasal en gotas al llegar a la sala de cuidados posoperatorios. Las variables de estudio incluyeron el dolor según la Escala Visual Análoga (EVA), el tiempo de inicio de acción del opioide y la analgesia lograda, así como los efectos derivados de su empleo. Resultados: la edad promedio fue 51 ± 2, predominó el sexo masculino con 55 por ciento de los casos, se evidenció una EVA promedio de todos los casos iniciales en 3. Al alta, 100 por ciento de los pacientes del grupo estudio poseían analgesia excelente (EVA 2), mientras que los controles poseían una EVA promedio en 5. El prurito fue el evento adverso más frecuente tras la administración de FENTANYL intranasal. Conclusiones: El empleo de un opioide de acción rápida (FENTANYL) es una medida de control del dolor posoperatorio excelente y segura(AU)
Introduction: Videolaparoscopic surgery has benefits for patients. Interventions with reduced times involve anesthetic techniques adjusted to them, which determines many difficulties when pain manifests in the care practice. The finding of patients with immediate postoperative pain motivated the study. Objective: To evaluate the effectiveness of a fast-acting opioid as an immediate postoperative analgesic administered by intranasal way. Method: A quasiexperimental study was developed, with two groups of patients (100 each) who underwent laparoscopic cholecystectomy at Dr. Luis Díaz Soto Central Military Hospital. The hundred patients under study were administered fentanyl 50 mcg as intranasal drops upon arriving at the postoperative care room. The study variables included pain according to the Visual Analogue Scale (VAS), the onset time of opioid action, and the analgesia achieved, as well as the effects derived from its use. Results: The average age was 51 ± 2, the male sex predominated with 55 percent of the cases, an average VAS of all the initial cases was evidenced in three. At discharge, 100 percent of the patients in the study group had excellent analgesia (VAS 2), whereas the controls had an average VAS in 5. Pruritus was the most frequent adverse event after the administration of intranasal fentanyl. Conclusions: The use of a fast-acting opioid (fentanyl) is an excellent and safe postoperative pain control measure(AU)
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Humanos , Dolor Postoperatorio/prevención & control , Dolor Postoperatorio/tratamiento farmacológico , Colecistectomía Laparoscópica/métodos , Analgésicos/uso terapéutico , Fentanilo/uso terapéutico , Ensayos Clínicos Controlados no Aleatorios como AsuntoRESUMEN
Fentanyl is a strong opioid analgesic, which is commonly used in the form of a transdermal patch for the treatment of chronic cancer pain. An intranasal route of fentanyl administration is a novel treatment for breakthrough cancer pain (BTCP). The prevalence, assessment, and management of BTCP is outlined in this paper, and basic pharmacodynamic and pharmacokinetic properties, dosing guidelines, and clinical experience with the use of intranasal fentanyl in this indication are discussed. Intranasal fentanyl is an attractive and convenient mode of BTCP treatment in opioid-tolerant patients due to its quick onset and short duration of action, noninvasive administration route, high bioavailability, and avoidance of a hepatic first-pass effect. Until now, few clinical trials have been conducted with intranasal fentanyl, but all have confirmed its usefulness and acceptability in BTCP treatment. Intranasal fentanyl may be used in opioid-tolerant patients without nasal pathologies. The dose should be titrated in each patient regardless of the regular opioid dose administered. Future studies should compare intranasal fentanyl with other fentanyl formulations used for BTCP management, and with analgesia, adverse effects, and quality of life taken into consideration.