V Domingo-Triadó1, M D López Alarcón2, F Villegas Estévez3, C Alba Moratillas4, B Massa Domínguez5, F Palomares Payá6, A Mínguez Martí2, L Debón Vicent7. 1. Unidad del Dolor, Hospital Lluís Alcanyís, Xàtiva, Valencia, España. Electronic address: vdt5677@ono.com. 2. Unidad del Dolor, Hospital General Universitario de Valencia, Valencia, España. 3. Unidad del Dolor, Consorcio Hospital Provincial de Castellón, Castellón, España. 4. Unidad de Úlceras, Hospital Clínico Universitario de Valencia, Valencia, España. 5. Unidad de Úlceras, Hospital General Universitario de Valencia, Valencia, España. 6. Unidad de Hospitalización Domiciliaria, Hospital de Villajoyosa, Villajoyosa, Alicante, España. 7. Oficina de Farmacia, Castellón, España.
Abstract
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.
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.
Authors: F Dámaso Fernández-Ginés; Manuel Cortiñas-Sáenz; Desirée Agudo-Ponce; Ana Navajas-Gómez de Aranda; José A Morales-Molina; Carmen Fernández-Sánchez; Francisco Sierra-García; Héctor Mateo-Carrasco Journal: Int Wound J Date: 2019-11-25 Impact factor: 3.315