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Treatment of the Febrile Child: What is the Evidence?. Mona Nabulsi-Khalil, MD MSc Associate Professor of Pediatrics Department of Pediatrics American University of Beirut. OUTLINE. Fever: Friend or Foe Fever phobia Why do we treat fever? Non-pharmacologic Rx Pharmacologic Rx

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treatment of the febrile child what is the evidence

Treatment of the Febrile Child: What is the Evidence?

Mona Nabulsi-Khalil, MD MSc

Associate Professor of Pediatrics

Department of Pediatrics

American University of Beirut

outline
OUTLINE

Fever: Friend or Foe

Fever phobia

Why do we treat fever?

Non-pharmacologic Rx

Pharmacologic Rx

Adverse effects of Rx

historical perspective
Historical Perspective
  • Hippocrates: Fever as beneficial sign during infection
  • Thomas Sydenham (1624-1689): “…nature’s engine …to remove her enemy…”
  • Liebermeister (1800’s): fever as regulation of body temp. at higher level
fever friend or foe
Fever: Friend or Foe?

Beneficial host response:

  • Animal studies
  • Human studies
fever friend or foe5
Fever: Friend or foe?

Harmful consequences:

  • ↑O2 consumption & CO2 production
  • ↑Cardiac output & fluid requirement
  • Febrile seizures in predisposed children
  • Delirium, coma  death > 410 C
fever phobia
Feverphobia
  • Barton Schmitt: Unrealistic concerns about fever causing harm
  • Scmitt (AJDC 1980):
    • 94% of parents believed fever had side effects
    • 63% worried about serious harm
    • 18% brain damage at T<38.90 C
    • 16% lethal & reaches 48.90 if untreated
fever phobia7
Fever phobia
  • Crocetti, et al, Pediatrics 2001
    • 91% of parents: fever harmful
    • 21%: brain damage; 14%: death
    • >50%: check fever hourly
    • 25%: gave antipyretics for temp <380 C
    • 85%: awaken child from sleep to give antipyretic
fever phobia8
Fever phobia
  • Crocetti, et al:
    • 14-44% gave acetaminophen or ibuprofen at more frequently than indicated
    • Phobic parents were more likely to have doctors that worry about fever
why do we treat fever
Why do we treat fever?
  • Relieve child expert opinion
  • Decrease on metabolic cost (cardiac, pulmonary dis.) expert opinion
  • Avoid febrile seizure (not true)

Evidence level Ia

  • Relieve parental anxiety (fever phobia)!!
non pharmacologic rx
Non-pharmacologic Rx
  • Remove excessive clothing/blankets heat dissipation (Exp. Op.)
  • Avoid excessive activity heat production (Exp. Op.)
  • Hydration insensible losses; blood flow (Exp. Op.)
  • Physical methods (Evidence level 1a)
physical methods of antipyresis
Physical methods of antipyresis

Heat loss:conduction, convection, evaporation

  • Tepid water spongingAlexander the Great
  • Cooling blankets
  • Circulating fans
physical methods of antipyresis13
Physical methods of antipyresis

Meremikwu & Oyo-Ita. Cochrane Database Syst Rev 2003

  • Benefits & harms of physical methods
  • RCT’s; Physical method vs placebo/no Rx; ± antipyretic
  • 1 RCT (n=30): physical methods vs placebo

similar % afebrile at 1 hr

meremikwu oyo ita cochrane database syst rev 2003
Meremikwu & Oyo-Ita. Cochrane Database Syst Rev 2003

2 RCTs (n=125): physical methods + antipyretic vs antipyretic

RR (% afebrile at 1 hr):

11.76; 95%CI 3.39-40.79

1RCT (n=130): no diff.

AE in 3 trials:

Shivering & goose pimples

RR 5.09; 95%CI 1.56-16.60

pharmacologic antipyresis
Pharmacologic Antipyresis
  • Centrally-acting drugs: hypothalamic thermoregulatory center; inhibit synthesis of PG’s
  • Two main families:
    • Paracetamol: Central antipyretic action (acetaminophen)
    • NSAID’s: Central antipyretic action and peripheral anti-inflammatory action (ibuprofen)
acetaminophen
Acetaminophen
  • Absorption: 30-60 min
  • Maximum antipyresis: 3-4 hrs
  • Dose (oral): 10-15 mg/kg; Q4-6 hrs
  • Toxicity: large doses  fulminant hepatic failure  death
acetaminophen17
Acetaminophen
  • Meremikwu & Oyo-Ita. Cochrane Database Syst Rev 2002
  • RCTs: ACE vs. placebo/no RxORvs. physical methods
  • Few studies, limited data, heterogeneity
  • % afebrile at 2 hrs (vs. sponging):

2 RCTs; n=120

RR=1.84; 95%CI 0.94-3.61

No AE

rectal acetaminophen
Rectal Acetaminophen
  • Absorption: Irregular, variable, prolonged
  • Peak [serum]: 3.5 hrs
  • Dose: 30-45 mg/kg; Q4-6 hrs
rectal vs oral acataminophen
Rectal vs. Oral Acataminophen

Scolnick et al. Pediatrics 2002

  • 70 children (6m-6y); ambulatory (T0≥ 390C)
  • Oral ACE (15mg/kg), rectal ACE (15 mg/kg), rectal ACE (30 mg/kg)
  • 3-hr F/U: no diff. in max Δ in temp.
rectal vs oral acataminophen20
Rectal vs. Oral Acataminophen

Nabulsi et al. BMC Pediatrics 2005

  • Double-dummy, D-B, P-C RCT
  • 51 children (6m-13y); inpatients (T0 ≥ 38.50C)
  • 15mg/kg oral, 15mg/kg rectal, 35 mg/kg rectal
  • Hourly T0 x 6h
  • Similar antipyresis (ITT)

Time to max antipyresis: 3.6h; 95%CI (3.2-4.0)

Time to reduction by ≥ 10C: 2.4h; 95%CI (1.8- 3.1)

Δ T0 each hr (P=0.25; two-way ANOVA)

ibuprofen
Ibuprofen
  • Absorption: 1-2 hrs
  • Maximum antipyresis: 4 hrs
  • Oral dose: 5-10 mg/kg; Q 6-8 hrs
  • Toxicities: Renal, GI bleeding, anaphylaxis
ibuprofen vs acetaminophen
Ibuprofen vs. Acetaminophen

Perrot, et al. Arch Pediatr Adolsc Med 2004

  • Meta-anlaysis: RCTs single-dose ACE & IBU
  • Fever or pain; <18 yrs
  • IBU (5-10mg/kg) > ACE (10-15mg/kg) at 2, 4, 6 hrs post dose
perrot et al arch pediatr adolsc med 2004
Perrot, et al. Arch Pediatr Adolsc Med 2004

Fever:

  • IBU (5-10mg/kg) > ACE (10-15mg/kg)
  • Weighted effect sizes:
      • 0.19 SD; 95% CI 0.05-0.33 (at T2)
      • 0.31 SD; 95% CI 0.19-0.44 (at T4)
      • 0.33 SD; 95% CI 0.19-0.47 (at T6)
  • AE: similar to placebo
ibuprofen vs acetaminophen safety
Ibuprofen vs. Acetaminophen: Safety

Lesko & Mitchell. Pediatrics 1999

  • Incidence of serious AE
  • Children < 2 yrs
  • D-B, practitioner based RCT
  • IBU (5mg/kg), IBU (10mg/kg), ACE (12mg/kg)
  • 4-week F/U: similar rates of hospitalizations

1.4%; 95% CI 1.3%-1.6%

lesko mitchell pediatrics 1999
Lesko & Mitchell. Pediatrics 1999
  • No serious AE:
    • Acute renal failure
    • Anaphylaxis
    • Reye’s syndrome
    • Asthma
    • Bronchiolitis
    • Vomiting/gastritis
  • GI bleeding: 3 (IBU)
  • Short-term assessment!!
alternating ibuprofen acteminophen
Alternating Ibuprofen-Acteminophen
  • Common practice: physicians & care givers

Mayoral, et al. Pediatrics 2000

    • 50% of physicians
    • Young physicians (fever phobia!!)
alternating ibuprofen acteminophen27
Alternating Ibuprofen-Acteminophen

Nabulsi, et al. BMC Medicine 2006

- 38.5% of parents

- 84.3%: physician’s advice

- 13.7%: self-initiated

- 71.7%: “very effective”

alternating ibuprofen acteminophen28
Alternating Ibuprofen-Acteminophen

Wright & Liebelt. Clin Pediatr 2007

- 44% of parents

- 81%: physician’s advice

- 8%: self-initiated

- Frequency : 9% (2 hrs)

16% (3 hrs)

43% ( 4 hrs)

- 61%: written instructions

combined ibuprofen acteminophen
Combined Ibuprofen-Acteminophen

Erlewyn-Lajeunesse, et al. Arch Dis Child 2006

  • O-L RCT
  • 123 children (6m-10y); ER (T0 ≥ 38.0 0C)
  • Tympanic T0, T1, T2
  • Paracetamol 15mg/kg, IBU 5mg/kg, both
  • Δ at T1:

Both>Paracetam. 0.35 0C; 95%CI 0.10-0.60

Both=IBU 0.25 0C; 95%CI -0.01-0.50

alternating ibuprofen acteminophen30
Alternating Ibuprofen-Acteminophen

Sarrell, et al. Arch Pediatr Adolesc Med 2006

  • 464 children (6-36m), outpatients (T0 ≥ 38.4 0C)
  • ??D-B RCT
  • ACE 12.5mg/kg Q6h, IBU 5mg/kg Q8h, ACE/IBU Q4h (??blinding)
  • 3-day T, stress score, amount of drug, days absent from day care/work, fever recurrence, no. ED visits
alternating ibuprofen acteminophen31
Alternating Ibuprofen-Acteminophen

Sarrell, et al. Arch Pediatr Adolesc Med 2006

  • Loading doses: 25mg/kg ACE, 10mg/kg IBU
  • ACE/IBU (p<0.001):

lower mean T

more rapid ↓T

less stress score

less absenteeism

  • No AE in all groups
alternating ibuprofen acteminophen32
Alternating Ibuprofen-Acteminophen

Nabulsi, et al. BMC Medicine 2006

  • D-B, P-C RCT
  • 70 children (6m-12.8y); inpatients (T0 ≥ 38.8 0C)
  • IBU 10mg/kg at T0 , placebo at T4

IBU 10mg/kg at T0 , ACE 15mg/kg at T4

  • T0, T4-8
combined antipyretics risks
Combined antipyretics: ?risks
  • Potentiation of renal toxicity: case reports

Ibuprofen reduces glutathione production +acetaminphen renal toxicity (tubular necrosis)

antipyretics ae controversies
Antipyretics AE: controversies!
  • Asthma & IBU: Risk similar to ACE Lesko et al. Pediatrics 2002
  • Febrile sz & IBU or ACE: No ↓ in recurrences

van Stuijvenberg, et al. Pediatrics 1998

Baumann RJ. Pediatrics 1999

antipyretics ae controversies37
Antipyretics AE: controversies!
  • Invasive group A strep and NSAIDs:

- No ↑ risk necrotising GAS infections

- ? Association with non-invasive GAS infections and IBU

OR= 3.9; 95% CI 1.3-12 (Subgroup of combined antipyretic)

Lesko et al. Pediatrics 2001

should we treat fever
Should we treat fever?

“ .. antipyretics should not be given routinely to children with fever in developing countries; they should be reserved for the treatment of children with severe discomfort or high fever..”

WHO Programme for the Control of Acute Respiratory Infections. The management of fever in young children with acute respiratory infections in developing countries. Geneva: World Health Organization, WHO/ARI/93.30,1993

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