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

Peters, M; 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; Watkins, J; Wellman, P; Harrison, D; Rowan, K

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


Authors

M Peters

K Woolfall

I Khan

E Deja

P Mouncey

J Wulff

A Mason

R Agbecko

E Draper

B Fenn

D Gould

A Koelewyn

N Klein

C Mackerness

S Martin

L O'Neill

S Ray

P Ramnarayan

S Tibby

K Thorburn

LN Tume

J Watkins

P Wellman

D Harrison

K Rowan



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.

Citation

clinical pilot trial. Critical Care, 23, 69. https://doi.org/10.1186/s13054-019-2354-4

Journal Article Type Article
Acceptance Date Feb 10, 2019
Publication Date Mar 7, 2019
Deposit Date Sep 4, 2019
Publicly Available Date Sep 4, 2019
Journal Critical Care
Print ISSN 1574-4280
Electronic ISSN 1466-609X
Publisher Springer Verlag
Volume 23
Pages 69
DOI https://doi.org/10.1186/s13054-019-2354-4
Publisher URL https://doi.org/10.1186/s13054-019-2354-4
Related Public URLs https://ccforum.biomedcentral.com/
Additional Information Projects : FEVER Study

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