ABSTRACT
Objetivo. El presente estudio pretende establecer la eficacia y tolerabilidad de los opioides en el tratamiento del dolor en pacientes con úlceras cutáneas crónicas y dolor irruptivo incidental. Material y método. Estudio abierto, multicéntrico, prospectivo, no controlado, realizado en unidades del dolor y de úlceras de 5 hospitales de la Comunidad Valenciana. El criterio de inclusión fue dolor basal mayor o igual a 4 según la escala visual analógica o dolor irruptivo mayor o igual a 4 durante la cura. Los criterios de exclusión fueron alteraciones cognitivas, intolerancia a opioides y rechazo del paciente a dar el consentimiento. El protocolo estableció 5 momentos de evaluación: basal (primera visita), 15 días, un mes, 2 y 3 meses. La variable principal del estudio fue el dolor medido con la escala visual analógica en reposo, en movimiento y durante la cura. Se administraron opioides para el dolor basal y se administró fentanilo sublingual para el dolor irruptivo. Resultados. Treinta y dos pacientes (86,5%) completaron el estudio. El dolor basal experimentó una reducción media de 3,6 (DE 2,3) puntos en la escala visual analógica, el dolor en movimiento disminuyó 3,9 (DE 2,5), y el dolor durante la cura disminuyó 4,5 (DE 2,8), siendo en todos estadísticamente significativa (p < 0,001) desde el primer control. Catorce pacientes (43,8%) presentaron náuseas, 7 (21,9%), somnolencia y estreñimiento, 5 (15,6%), prurito, y uno (3,1%), vómitos. Conclusiones. Los resultados de nuestro estudio evidencian que el tratamiento con opioides en pacientes con úlceras cutáneas crónicas proporciona un alivio efectivo del dolor, tanto basalmente como durante la cura, con escasos efectos adversos (AU)
Objective. The aim of the study was to assess the efficacy and safety of opioids in the management of pain in those patients with chronic cutaneous ulcers and breakthrough/incidental pain. Material and method. An open-label, multicentre, prospective, uncontrolled study was conducted in the pain and ulcer units of 5 hospitals across the Comunidad Valenciana. Eligibility criteria were baseline pain 4 in the visual analogue scale or breakthrough procedural pain 4. Exclusion criteria were cognitive impairment, opioid intolerance, or patient refusal to provide informed consent. The protocol scheduled 5 controls: baseline (enrolment), 15 days, one month, 2 months, and 3 months. The main outcome measure of the study was the visual analogue scale score during rest, movement and procedures. Opioids were administered for release of the baseline pain, and sublingual fentanyl for breakthrough pain. Results. A total of 32 patients (86.5%) completed the study. Baseline pain achieved a mean improvement of 3.6 visual analogue scale points (SD 2.3), movement pain improved by 3.9 points (SD 2.5) and procedural pain improved by 4.5 points (SD 2.8), and the mean pain intensity improvement was statistically significant from the first control and at all controls thereafter (P < .001). Nausea was reported by 14 patients (43.8%), drowsiness and constipation by 7 (21.9%), itching by 5 (15.6%), and one (3.1%) reported vomiting. Conclusions. Structured assessment of pain is a key concept in the management of patient with chronic cutaneous ulcers. The results of this study suggest that opioid therapy provides clinically significant pain relief with few adverse effects (AU)
Subject(s)
Humans , Male , Female , Pain Management/methods , Fentanyl/therapeutic use , Administration, Sublingual , Skin Ulcer/diagnosis , Skin Ulcer/drug therapy , Chronic Pain/drug therapy , Fentanyl/metabolism , Skin Ulcer/metabolism , Treatment Outcome , Evaluation of the Efficacy-Effectiveness of Interventions , Analgesics, Opioid/therapeutic use , Pain/complications , Pain/drug therapy , Pain/etiologyABSTRACT
OBJECTIVE: The aim of the study was to assess the efficacy and safety of opioids in the management of pain in those patients with chronic cutaneous ulcers and breakthrough/incidental pain. MATERIAL AND METHOD: An open-label, multicentre, prospective, uncontrolled study was conducted in the pain and ulcer units of 5 hospitals across the Comunidad Valenciana. Eligibility criteria were baseline pain 4 in the visual analogue scale or breakthrough procedural pain 4. Exclusion criteria were cognitive impairment, opioid intolerance, or patient refusal to provide informed consent. The protocol scheduled 5 controls: baseline (enrolment), 15 days, one month, 2 months, and 3 months. The main outcome measure of the study was the visual analogue scale score during rest, movement and procedures. Opioids were administered for release of the baseline pain, and sublingual fentanyl for breakthrough pain. RESULTS: A total of 32 patients (86.5%) completed the study. Baseline pain achieved a mean improvement of 3.6 visual analogue scale points (SD 2.3), movement pain improved by 3.9 points (SD 2.5) and procedural pain improved by 4.5 points (SD 2.8), and the mean pain intensity improvement was statistically significant from the first control and at all controls thereafter (P<.001). Nausea was reported by 14 patients (43.8%), drowsiness and constipation by 7 (21.9%), itching by 5 (15.6%), and one (3.1%) reported vomiting. CONCLUSIONS: Structured assessment of pain is a key concept in the management of patient with chronic cutaneous ulcers. The results of this study suggest that opioid therapy provides clinically significant pain relief with few adverse effects.
