Kawade Anand, Dayma Girish, Apte Aditi, Roy Sudipto, Gondhali Arun, Juvekar Sanjay, Bavdekar Ashish
Vadu Rural Health Program KEM Hospital Research Centre Pune India.
Paediatr Neonatal Pain. 2021 Dec 26;3(4):170-175. doi: 10.1002/pne2.12068. eCollection 2021 Dec.
Routinely children are exposed to various procedures as a part of clinical care and/or research participation. Public health strategies to contain current COVID-19 pandemic demanded massive nasopharyngeal swab testing but limited data exist to confirm the extent of the pain and distress that result from this procedure. These data could help clinicians to formulate mitigation strategies, influence public health directives, and inform review boards/ethics committees to decide on risk-benefit ratio of the procedure. Hence, an observational study to assess perceived distress was nested in a phase IV alternate and reduced dose schedule trial of the pneumococcal conjugate vaccine (PCV) in which nasopharyngeal swab (NPS) was used to collect nasopharyngeal secretions as part of the study procedure. Out of 805 infant participants enrolled in the main study, a total of 425 infants were enrolled and observed for procedural distress at 18 weeks and 10 months of age using the Face Leg Activity Cry and Consolability (FLACC) Scale. The FLACC score and duration of cry were recorded. The mean FLACC score changed substantially from preprocedural to procedure in both age groups (from 0.08 to 5.8 at 18 weeks and from 0.5 to 7.007 at 10 months. = <.0001). The proportion of infants experiencing higher FLACC scores (7-10) indicating severe distress increased significantly from 22% (n = 95) at 18 weeks to 61% (n = 248) at 10 months ( < .0001). The mean duration of cry was significantly increased from 23.03 seconds at 18 weeks to 52.6 seconds at 10 months ( = .00). Nasopharyngeal swab collection produced substantial distress which increased with age. Adequate training of sample collectors and supporting parent engagement during procedure could help in reducing the distress.
儿童在日常临床护理和/或参与研究过程中会接受各种检查。为控制当前的新冠疫情，公共卫生策略要求进行大规模的鼻咽拭子检测，但关于该检查所导致的疼痛和痛苦程度的确认数据有限。这些数据有助于临床医生制定缓解策略、影响公共卫生指令，并为审查委员会/伦理委员会提供信息，以决定该检查的风险效益比。因此，在一项肺炎球菌结合疫苗（PCV）的IV期替代和减量时间表试验中纳入了一项观察性研究，以评估感知到的痛苦，该试验中使用鼻咽拭子（NPS）收集鼻咽分泌物作为研究程序的一部分。在主要研究中登记的805名婴儿参与者中，共有425名婴儿在18周和10个月大时使用面部腿部活动哭声和安慰性（FLACC）量表进行登记并观察其操作痛苦情况。记录了FLACC评分和哭闹持续时间。两个年龄组从操作前到操作过程中，平均FLACC评分均有显著变化（18周时从0.08变为5.8，10个月时从0.5变为7.007，P<0.0001）。FLACC评分较高（7 - 10）表明严重痛苦的婴儿比例从18周时的22%（n = 95）显著增加到10个月时的61%（n = 248）（P<0.0001）。平均哭闹持续时间从18周时的23.03秒显著增加到10个月时的52.6秒（P = 0.00）。鼻咽拭子采集会产生相当大的痛苦，且随年龄增长而增加。对样本采集者进行充分培训并在操作过程中支持家长参与，可能有助于减轻痛苦。
