Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial

Peters, M ORCID: https://orcid.org/0000-0002-2547-8209, Woolfall, K, Khan, I, Deja, E, Mouncey, P, Wulff, J, Mason, A, Agbecko, R, Draper, E, Fenn, B, Gould, D, Koelewyn, A, Klein, N, Mackerness, C, Martin, S, O'Neill, L, Ray, S, Ramnarayan, P, Tibby, S, Thorburn, K, Tume, LN ORCID: https://orcid.org/0000-0002-2547-8209, Watkins, J, Wellman, P, Harrison, D and Rowan, K 2019, 'Permissive versus restrictive temperature thresholds in critically ill children with fever and infection: a multicentre randomized clinical pilot trial' , Critical Care, 23 , p. 69.

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Abstract

Background: Fever improves pathogen control at a significant metabolic cost. No randomized clinical trials (RCT) have compared fever treatment thresholds in critically ill children. We performed a pilot RCT to determine whether a definitive trial of a permissive approach to fever in comparison to current restrictive practice is feasible in critically ill children with suspected infection. Methods: An open, parallel-group pilot RCT with embedded mixed methods perspectives study in four UK paediatric intensive care units (PICUs) and associated retrieval services. Participants were emergency PICU admissions aged > 28 days to < 16 years receiving respiratory support and supplemental oxygen. Subjects were randomly assigned to permissive (antipyretic interventions only at ≥ 39.5 °C) or restrictive groups (antipyretic interventions at ≥ 37.5 °C) whilst on respiratory support. Parents were invited to complete a questionnaire or take part in an interview. Focus groups were conducted with staff at each unit. Outcomes were measures of feasibility: recruitment rate, protocol adherence and acceptability, between group separation of temperature and safety. Results: One hundred thirty-eight children met eligibility criteria of whom 100 (72%) were randomized (11.1 patients per month per site) without prior consent (RWPC). Consent to continue in the trial was obtained in 87 cases (87%). The mean maximum temperature (95% confidence interval) over the first 48 h was 38.4 °C (38.2–38.6) in the restrictive group and 38.8 °C (38.6–39.1) in the permissive group, a mean difference of 0.5 °C (0.2–0.8). Protocol deviations were observed in 6.8% (99/1438) of 6-h time periods and largely related to patient comfort in the recovery phase. Length of stay, duration of organ support and mortality were similar between groups. No pre-specified serious adverse events occurred. Staff (n = 48) and parents (n = 60) were supportive of the trial, including RWPC. Suggestions were made to only include invasively ventilated children for the duration of intubation. Conclusion: Uncertainty around the optimal fever threshold for antipyretic intervention is relevant to many emergency PICU admissions. A more permissive approach was associated with a modest increase in mean maximum temperature. A definitive trial should focus on the most seriously ill cases in whom antipyretics are rarely used for their analgesic effects alone.

Item Type:	Article
Schools:	Schools > School of Health and Society
Journal or Publication Title:	Critical Care
Publisher:	BioMed Central
ISSN:	1364-8535
Related URLs:	Publication
Funders:	NIHR HTA
Depositing User:	Dr Lyvonne Tume
Date Deposited:	04 Sep 2019 14:01
Last Modified:	16 Feb 2022 02:35
URI:	http://usir.salford.ac.uk/id/eprint/52204

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