Dexibuprofen for fever in children with upper respiratory tract infection

Chang Keun Kim, Zak Callaway, Ji-Tae Choung, Jin Ho Yu, Kye Shik Shim, Eun Mi Kwon, Young Yull Koh

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background The aim of this study was to investigate the safety and efficacy of dexibuprofen compared to ibuprofen. Methods This double-blind, double-dummy study enrolled patients from January 2008 to May 2009 presenting at one of five tertiary care centers in Seoul, Korea with febrile illness who were then given one of three active treatments: one dose of dexibuprofen 2.5 or 5 mg/kg (DEX 1); dexibuprofen 3.5 or 7 mg/kg (DEX 2); or ibuprofen 5 or 10 mg/kg (control) syrup. Those with a temperature <38.5°C were given the lower dose. Temperature was measured every hour for 4 h. Primary study outcome was mean change in temperature 4 h after one dose. Results A total of 264 children (aged 6 months-14 years) with febrile illness due to upper respiratory tract infection were consecutively sampled and screened, with 260 randomized. No patients withdrew due to adverse effects. Mean temperature change after 4 h (mean ± SD: DEX 1, 0.99 ± 0.84°C; DEX 2, 1.12 ± 0.92°C; control, 1.38 ± 0.84°C) differed only between DEX 1 and controls (P = 0.007, 95% confidence interval [CI]: -0.61 to -0.15). When groups were subdivided according to initial temperature, there were no significant differences in mean temperature change after 4 h between DEX 2 subgroups (<38.5°C, 0.88 ± 0.86°C; ≥38.5°C, 1.46 ± 0.90°C) and controls (1.07 ± 0.84°C and 1.72 ± 0.91°C, respectively), but there was a significant difference between DEX 1 (≥38.5°C, 1.25 ± 0.76°C) and controls (P = 0.0222, 95%CI: -0.80 to -0.13). There were no significant differences in adverse events among groups. Conclusion Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.

Original languageEnglish
Pages (from-to)443-449
Number of pages7
JournalPediatrics International
Volume55
Issue number4
DOIs
Publication statusPublished - 2013 Aug 1

Fingerprint

Respiratory Tract Infections
Fever
Temperature
Ibuprofen
Confidence Intervals
Korea
Double-Blind Method
Tertiary Care Centers
dexibuprofen
Outcome Assessment (Health Care)
Safety

Keywords

  • dexibuprofen
  • fever
  • ibuprofen
  • randomized controlled trial
  • upper respiratory tract infection

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Kim, C. K., Callaway, Z., Choung, J-T., Yu, J. H., Shim, K. S., Kwon, E. M., & Koh, Y. Y. (2013). Dexibuprofen for fever in children with upper respiratory tract infection. Pediatrics International, 55(4), 443-449. https://doi.org/10.1111/ped.12125

Dexibuprofen for fever in children with upper respiratory tract infection. / Kim, Chang Keun; Callaway, Zak; Choung, Ji-Tae; Yu, Jin Ho; Shim, Kye Shik; Kwon, Eun Mi; Koh, Young Yull.

In: Pediatrics International, Vol. 55, No. 4, 01.08.2013, p. 443-449.

Research output: Contribution to journalArticle

Kim, CK, Callaway, Z, Choung, J-T, Yu, JH, Shim, KS, Kwon, EM & Koh, YY 2013, 'Dexibuprofen for fever in children with upper respiratory tract infection', Pediatrics International, vol. 55, no. 4, pp. 443-449. https://doi.org/10.1111/ped.12125
Kim, Chang Keun ; Callaway, Zak ; Choung, Ji-Tae ; Yu, Jin Ho ; Shim, Kye Shik ; Kwon, Eun Mi ; Koh, Young Yull. / Dexibuprofen for fever in children with upper respiratory tract infection. In: Pediatrics International. 2013 ; Vol. 55, No. 4. pp. 443-449.
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abstract = "Background The aim of this study was to investigate the safety and efficacy of dexibuprofen compared to ibuprofen. Methods This double-blind, double-dummy study enrolled patients from January 2008 to May 2009 presenting at one of five tertiary care centers in Seoul, Korea with febrile illness who were then given one of three active treatments: one dose of dexibuprofen 2.5 or 5 mg/kg (DEX 1); dexibuprofen 3.5 or 7 mg/kg (DEX 2); or ibuprofen 5 or 10 mg/kg (control) syrup. Those with a temperature <38.5°C were given the lower dose. Temperature was measured every hour for 4 h. Primary study outcome was mean change in temperature 4 h after one dose. Results A total of 264 children (aged 6 months-14 years) with febrile illness due to upper respiratory tract infection were consecutively sampled and screened, with 260 randomized. No patients withdrew due to adverse effects. Mean temperature change after 4 h (mean ± SD: DEX 1, 0.99 ± 0.84°C; DEX 2, 1.12 ± 0.92°C; control, 1.38 ± 0.84°C) differed only between DEX 1 and controls (P = 0.007, 95{\%} confidence interval [CI]: -0.61 to -0.15). When groups were subdivided according to initial temperature, there were no significant differences in mean temperature change after 4 h between DEX 2 subgroups (<38.5°C, 0.88 ± 0.86°C; ≥38.5°C, 1.46 ± 0.90°C) and controls (1.07 ± 0.84°C and 1.72 ± 0.91°C, respectively), but there was a significant difference between DEX 1 (≥38.5°C, 1.25 ± 0.76°C) and controls (P = 0.0222, 95{\%}CI: -0.80 to -0.13). There were no significant differences in adverse events among groups. Conclusion Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.",
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AU - Choung, Ji-Tae

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AU - Shim, Kye Shik

AU - Kwon, Eun Mi

AU - Koh, Young Yull

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N2 - Background The aim of this study was to investigate the safety and efficacy of dexibuprofen compared to ibuprofen. Methods This double-blind, double-dummy study enrolled patients from January 2008 to May 2009 presenting at one of five tertiary care centers in Seoul, Korea with febrile illness who were then given one of three active treatments: one dose of dexibuprofen 2.5 or 5 mg/kg (DEX 1); dexibuprofen 3.5 or 7 mg/kg (DEX 2); or ibuprofen 5 or 10 mg/kg (control) syrup. Those with a temperature <38.5°C were given the lower dose. Temperature was measured every hour for 4 h. Primary study outcome was mean change in temperature 4 h after one dose. Results A total of 264 children (aged 6 months-14 years) with febrile illness due to upper respiratory tract infection were consecutively sampled and screened, with 260 randomized. No patients withdrew due to adverse effects. Mean temperature change after 4 h (mean ± SD: DEX 1, 0.99 ± 0.84°C; DEX 2, 1.12 ± 0.92°C; control, 1.38 ± 0.84°C) differed only between DEX 1 and controls (P = 0.007, 95% confidence interval [CI]: -0.61 to -0.15). When groups were subdivided according to initial temperature, there were no significant differences in mean temperature change after 4 h between DEX 2 subgroups (<38.5°C, 0.88 ± 0.86°C; ≥38.5°C, 1.46 ± 0.90°C) and controls (1.07 ± 0.84°C and 1.72 ± 0.91°C, respectively), but there was a significant difference between DEX 1 (≥38.5°C, 1.25 ± 0.76°C) and controls (P = 0.0222, 95%CI: -0.80 to -0.13). There were no significant differences in adverse events among groups. Conclusion Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.

AB - Background The aim of this study was to investigate the safety and efficacy of dexibuprofen compared to ibuprofen. Methods This double-blind, double-dummy study enrolled patients from January 2008 to May 2009 presenting at one of five tertiary care centers in Seoul, Korea with febrile illness who were then given one of three active treatments: one dose of dexibuprofen 2.5 or 5 mg/kg (DEX 1); dexibuprofen 3.5 or 7 mg/kg (DEX 2); or ibuprofen 5 or 10 mg/kg (control) syrup. Those with a temperature <38.5°C were given the lower dose. Temperature was measured every hour for 4 h. Primary study outcome was mean change in temperature 4 h after one dose. Results A total of 264 children (aged 6 months-14 years) with febrile illness due to upper respiratory tract infection were consecutively sampled and screened, with 260 randomized. No patients withdrew due to adverse effects. Mean temperature change after 4 h (mean ± SD: DEX 1, 0.99 ± 0.84°C; DEX 2, 1.12 ± 0.92°C; control, 1.38 ± 0.84°C) differed only between DEX 1 and controls (P = 0.007, 95% confidence interval [CI]: -0.61 to -0.15). When groups were subdivided according to initial temperature, there were no significant differences in mean temperature change after 4 h between DEX 2 subgroups (<38.5°C, 0.88 ± 0.86°C; ≥38.5°C, 1.46 ± 0.90°C) and controls (1.07 ± 0.84°C and 1.72 ± 0.91°C, respectively), but there was a significant difference between DEX 1 (≥38.5°C, 1.25 ± 0.76°C) and controls (P = 0.0222, 95%CI: -0.80 to -0.13). There were no significant differences in adverse events among groups. Conclusion Dexibuprofen (3.5 or 7 mg/kg) is as effective and tolerable as ibuprofen for fever caused by upper respiratory tract infection in children.

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