From the Arnold Palmer Hospital for Children, Orlando Health.
Orlando Health, Orlando, FL.
Pediatr Emerg Care. 2022 Aug 1;38(8):363-366. doi: 10.1097/PEC.0000000000002779. Epub 2022 Jul 5.
Painful infectious mouth conditions such as herpangina, hand-foot-and-mouth disease, and herpetic gingivostomatitis can cause pain, dehydration, and hospitalization in young children. Treatment for these conditions is generally supportive and directed toward pain relief from ulcerative lesions, thus facilitating oral intake, and preventing dehydration. Attempts at oral therapy at home and in the emergency department are often refused and immediately spit back out. This study evaluated the efficacy of intranasal fentanyl (INF) compared with a commonly used oral (PO) acetaminophen/hydrocodone formulation for the treatment of children with painful infectious mouth conditions.
This study was a prospective, nonblinded, randomized controlled noninferiority trial conducted in an academic tertiary care pediatric emergency department. The study enrolled children between the ages of 6 months and 18 years with painful infectious mouth lesions and poor oral intake. Patients were randomized to receive either INF (1.5 μg/kg, intervention) or PO acetaminophen/hydrocodone (0.15 mg/kg, control) based on the dose of hydrocodone. The primary outcome was volume of fluid intake per body weight (in milliliters per kilogram) 60 minutes after analgesic administration. Secondary outcomes included pain scores using a validated visual assessment scale (VAS; 1, no pain; 10, worst pain), hydration score (VAS; 1, well hydrated; 4, very dehydrated), admission rate and overall satisfaction score (VAS; 1, worst; 7, best). A priori power analysis indicated that 34 patients would achieve an 81% power with an α value of 0.05.
Of the 34 patients enrolled, 17 were randomized to INF and 17 to PO. The demographics between both groups were similar in age, weight, sex, and race. There were no significant differences in parental perception of pain ( P = 0.69) or hydration status ( P = 0.78). Oral fluid intake at 60 minutes was 20 mL/kg for INF versus 18 mL/kg for PO ( P = 0.53). Pain scores at 15 and 30 minutes were 1.7 versus 2.9 ( P = 0.09) and 0.6 versus 1.6 ( P = 0.59). Parental perceptions of pain and hydration status at 60 minutes were 2.2 versus 2.4 ( P = 0.77) and 1.7 versus 1.5 ( P = 0.37). Overall parental satisfaction was 6.4 for INF versus 6.5 for PO ( P = 0.71), and admission rate was 0 vs 12% ( P = 0.49). There were no adverse events such as respiratory, cardiac, or central nervous system depression in either group.
Intranasal fentanyl seems to be a safe and effective alternative to acetaminophen with hydrocodone in reducing pain and improving hydration status in children with painful infectious mouth lesions and poor oral intake.
疱疹性咽峡炎、手足口病和疱疹性龈口炎等疼痛性传染性口腔疾病可导致幼儿出现疼痛、脱水和住院。这些疾病的治疗通常是支持性的，旨在缓解溃疡性病变引起的疼痛，从而促进口腔摄入并预防脱水。在家中或急诊科尝试口腔治疗时，药物往往会被拒绝并立即吐出。本研究评估了与常用的口服（PO）对乙酰氨基酚/氢可酮制剂相比，鼻内芬太尼（INF）治疗疼痛性传染性口腔疾病儿童的疗效。
这是一项在学术性三级儿童急诊科进行的前瞻性、非盲、随机对照非劣效性试验。该研究纳入了年龄在 6 个月至 18 岁之间、患有疼痛性传染性口腔病变和摄入不良的儿童。患者根据氢可酮的剂量随机接受 INF（1.5 μg/kg，干预组）或 PO 对乙酰氨基酚/氢可酮（0.15 mg/kg，对照组）治疗。主要结局是镇痛后 60 分钟内每公斤体重的液体摄入量（毫升/公斤）。次要结局包括使用经过验证的视觉评估量表（VAS；1，无痛；10，最痛）评估的疼痛评分、液体摄入评分（VAS；1，水分充足；4，严重脱水）、入院率和总体满意度评分（VAS；1，最差；7，最好）。预先进行的功效分析表明，在 α 值为 0.05 时，34 例患者将达到 81%的功效。
在纳入的 34 例患者中，17 例随机分配至 INF 组，17 例随机分配至 PO 组。两组在年龄、体重、性别和种族方面无显著差异。父母对疼痛的感知（P=0.69）或液体摄入状态（P=0.78）无显著差异。INF 组 60 分钟时的口服液体摄入量为 20 毫升/公斤，PO 组为 18 毫升/公斤（P=0.53）。15 分钟和 30 分钟时的疼痛评分分别为 1.7 分和 2.9 分（P=0.09）和 0.6 分和 1.6 分（P=0.59）。60 分钟时父母对疼痛和液体摄入状态的感知分别为 2.2 分和 2.4 分（P=0.77）和 1.7 分和 1.5 分（P=0.37）。INF 组的总体父母满意度为 6.4 分，PO 组为 6.5 分（P=0.71），入院率为 0%与 12%（P=0.49）。两组均无呼吸、心脏或中枢神经系统抑制等不良事件。
与口服对乙酰氨基酚/氢可酮相比，鼻内芬太尼似乎是一种安全有效的替代药物，可减轻疼痛并改善疼痛性传染性口腔病变和摄入不良儿童的液体摄入状态。
