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Comparison of Multidose Ibuprofen and Acetaminophen Therapy in Febrile Children

Comparison of Multidose Ibuprofen and Acetaminophen Therapy in Febrile Children Abstract • Objective. —To determine whether febrile children receiving 2.5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered. Design. —Randomized, double-blind, multidose, parallel-group, variable-duration (24 to 48 hours) clinical trial. Setting. —The academically affiliated Children's Hospital in Columbus, Ohio. Participants. —64 febrile (defined as oral or rectal temperature of 39°C to 40.5°C) but otherwise healthy children aged 6 months to 11 years 7 months randomly assigned to one of the four drug regimens. Interventions. —Treatment with either ibuprofen or acetaminophen as described above. Administration of antibiotics or intravenous fluids was allowed only after at least 24 hours of treatment with the assigned drug. Measurements/Main Results. —In 61 of the 64 evaluable patients, treatments were effective and well tolerated during the entire study. While the rates of temperature reduction and maximal reduction of fever after administration of the initial dose were equal for patients receiving 10-mg/kg ibuprofen therapy and 15-mg/kg acetaminophen therapy, and both regimens were more effective than smaller doses of ibuprofen in reducing fever, after the second dose (and continuing to the end of the study) there were no statistically significant differences in temperature response among the treatment groups. Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35.6°C; all three patients were in the acetaminophen group), and one because of gastrointestinal distress (this child was in the group receiving 2.5-mg/kg ibuprofen therapy). No other significant symptoms or adverse laboratory or physical findings were noted. While further confirmatory studies are needed, ibuprofen liquid (10 mg/kg) and acetaminophen elixir (15 mg/kg) administered every 6 hours for 24 to 48 hours appeared to be most effective in reducing fever. These two regimens were equally effective and equally tolerated in febrile children. Lower ibuprofen doses (2.5 and 5 mg/kg) were less effective than acetaminophen and 10-mg/kg ibuprofen therapy after the initial dose but were at least equally effective as these two higher-dose regimens thereafter.(AJDC. 1992;146:626-632) References 1. Styrt B, Sugarman B. Antipyresis and fever . Arch Intern Med . 1990;150:1589-1597.Crossref 2. Alexander ER, Rosa F, Hartz S, et al. Aspirin and Reye syndrome . Pediatrics . 1982;69:810-812. 3. Hurwitz ES, Barrett MJ, Bregman D, et al. Public Health Service Study on Reye's syndrome and medications . N Engl J Med . 1985;313:849-857.Crossref 4. Labelling for salicylate-containing drug products . Federal Register . (December 28) , 1982;47:57886. 5. Done AK. Aspirin overdosage: incidence, diagnosis, and management . Pediatrics . 1978;62S:890-897. 6. Mitchell AA, Lovejoy FH, Slone D, Shapiro S. Acetaminophen and aspirin: prescription, use, and accidental ingestion among children . AJDC . 1982;136:976-979. 7. Prescott LF. Hepatotoxicity of mild analgesics . Br J Clin Pharmacol . 1980;10:373S-379S.Crossref 8. Rumack BH. Acetaminophen: acute overdose toxicity in children . Drug Intell Clin Pharm . 1985;19:911-912. 9. Flaks A, Flaks B. Induction of liver cell tumours in IF mice by paracetamol . Carcinogenesis . 1983;4:363-368.Crossref 10. Ibuprofen vs acetaminophen in children . Med Lett Drug Ther . 1989;31:109-110. 11. Laska EM, Sunshine A, Marrero I, et al. The correlation between blood levels of ibuprofen and clinical analgesic response . Clin Pharmacol Ther . 1986;40:1-7.Crossref 12. Giannini EH, Brewer EJ, Miller ML, et al. Ibuprofen suspension in the treatment of juvenile rheumatoid arthritis . J Pediatr . 1990;117:645-652.Crossref 13. Simila S, Kouvalainen K, Keinanen S. Oral antipyretic therapy . Scand J Rheumatol . 1976;5:81-83.Crossref 14. Keinanen-Kiukaanniemi S, Simila S, Kouvalainen K. Oral antipyretic therapy evaluation of the propionic acid derivatives ibuprofen, ketoprofen, fenoprofen, and naproxen . Pediatr Padol . 1980;15:239-244. 15. Heremans G, Dehaen F, Rom N, Ramet J, Verboven M. A Single-blind, parallel-group study investigating the antipyretic properties of ibuprofen syrup versus acetylsalicylic acid syrup in febrile children . Br J Clin Pract . 1988;42:245-247. 16. Kandoth PW, Joshi MK, Joshi VR, Satoskar RJ. Comparative evaluation of antipyretic activity of ibuprofen and aspirin in children with pyrexia of varied aetiology . J Int Med Res . 1984;12:292-297. 17. Amdekar YK, Desai RZ. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia . Br J Clin Pract . 1985;39:140-143. 18. Kotob A. A comparative study of two dosage levels of ibuprofen syrup in children with pyrexia . J Int Med Res . 1985;13:122-126. 19. Barbosa MH, Dias PG, Esteves A. Comparative antipyretic study of ibuprofen (suspension) and paracetamol (suppositories) . O Medico . 1983;108:305-307. 20. Phadke MA, Paranjape PV, Joshi AS. Ibuprofen in children with infective disorders: antipyretic efficacy . Br J Clin Pract . 1985;39:437-440. 21. Wilson G, Guerra AJ, Santos NT. Comparative study of the antipyretic effect of ibuprofen (oral suspension) and paracetamol (suppositories) in paediatrics . J Int Med Res . 1984;12:250-254. 22. Walson PD, Galletta G, Braden NJ, Alexander L. Ibuprofen, acetaminophen, and placebo treatment of febrile children . Clin Pharmacol Ther . 1989;46:9-17.Crossref 23. Kauffman RE, Alexander LA, Scheinbaum ML. Ibuprofen suspension in children . Pediatr Res . 1989;25:67A. Abstract. 24. Hall AH, Smolinske SC, Conrad FL, et al. Ibuprofen overdose: 126 cases . Ann Emerg Med . 1986;15:1308-1313.Crossref 25. Temple AR. Pediatric dosing of acetaminophen . Pediatr Pharmacol . 1983;3:321-327. 26. WR Snodgrass. Antipyresis: how about ibuprofen . Pediatr Ther Toxicol . 1989;3:47-48. 27. Walson PD, Galletta G, Chomilo F, Graves P, Alexander L, Scheinbaum ML. Ibuprofen liquid: multidose treatment of febrile children . Eur J Pharmacol . 1989;36( (suppl) ):A154. Abstract. 28. Wilson JT, Brown RD, Bocchini JA, Kearns GL. Efficacy, disposition and pharmacodynamics of aspirin, acetaminophen and choline salicylate in young febrile children . Ther Drug Monit . 1982;4:147-180.Crossref 29. Mazur LJ, Jones TM, Kozinetz CA. Temperature response to acetaminophen and risk of occult bacteremia: a case-control study . J Pediatr . 1989;115:888-891.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Diseases of Children American Medical Association

Comparison of Multidose Ibuprofen and Acetaminophen Therapy in Febrile Children

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References (33)

Publisher
American Medical Association
Copyright
Copyright © 1992 American Medical Association. All Rights Reserved.
ISSN
0002-922X
DOI
10.1001/archpedi.1992.02160170106025
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Abstract

Abstract • Objective. —To determine whether febrile children receiving 2.5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered. Design. —Randomized, double-blind, multidose, parallel-group, variable-duration (24 to 48 hours) clinical trial. Setting. —The academically affiliated Children's Hospital in Columbus, Ohio. Participants. —64 febrile (defined as oral or rectal temperature of 39°C to 40.5°C) but otherwise healthy children aged 6 months to 11 years 7 months randomly assigned to one of the four drug regimens. Interventions. —Treatment with either ibuprofen or acetaminophen as described above. Administration of antibiotics or intravenous fluids was allowed only after at least 24 hours of treatment with the assigned drug. Measurements/Main Results. —In 61 of the 64 evaluable patients, treatments were effective and well tolerated during the entire study. While the rates of temperature reduction and maximal reduction of fever after administration of the initial dose were equal for patients receiving 10-mg/kg ibuprofen therapy and 15-mg/kg acetaminophen therapy, and both regimens were more effective than smaller doses of ibuprofen in reducing fever, after the second dose (and continuing to the end of the study) there were no statistically significant differences in temperature response among the treatment groups. Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35.6°C; all three patients were in the acetaminophen group), and one because of gastrointestinal distress (this child was in the group receiving 2.5-mg/kg ibuprofen therapy). No other significant symptoms or adverse laboratory or physical findings were noted. While further confirmatory studies are needed, ibuprofen liquid (10 mg/kg) and acetaminophen elixir (15 mg/kg) administered every 6 hours for 24 to 48 hours appeared to be most effective in reducing fever. These two regimens were equally effective and equally tolerated in febrile children. Lower ibuprofen doses (2.5 and 5 mg/kg) were less effective than acetaminophen and 10-mg/kg ibuprofen therapy after the initial dose but were at least equally effective as these two higher-dose regimens thereafter.(AJDC. 1992;146:626-632) References 1. Styrt B, Sugarman B. Antipyresis and fever . Arch Intern Med . 1990;150:1589-1597.Crossref 2. Alexander ER, Rosa F, Hartz S, et al. Aspirin and Reye syndrome . Pediatrics . 1982;69:810-812. 3. Hurwitz ES, Barrett MJ, Bregman D, et al. Public Health Service Study on Reye's syndrome and medications . N Engl J Med . 1985;313:849-857.Crossref 4. Labelling for salicylate-containing drug products . Federal Register . (December 28) , 1982;47:57886. 5. Done AK. Aspirin overdosage: incidence, diagnosis, and management . Pediatrics . 1978;62S:890-897. 6. Mitchell AA, Lovejoy FH, Slone D, Shapiro S. Acetaminophen and aspirin: prescription, use, and accidental ingestion among children . AJDC . 1982;136:976-979. 7. Prescott LF. Hepatotoxicity of mild analgesics . Br J Clin Pharmacol . 1980;10:373S-379S.Crossref 8. Rumack BH. Acetaminophen: acute overdose toxicity in children . Drug Intell Clin Pharm . 1985;19:911-912. 9. Flaks A, Flaks B. Induction of liver cell tumours in IF mice by paracetamol . Carcinogenesis . 1983;4:363-368.Crossref 10. Ibuprofen vs acetaminophen in children . Med Lett Drug Ther . 1989;31:109-110. 11. Laska EM, Sunshine A, Marrero I, et al. The correlation between blood levels of ibuprofen and clinical analgesic response . Clin Pharmacol Ther . 1986;40:1-7.Crossref 12. Giannini EH, Brewer EJ, Miller ML, et al. Ibuprofen suspension in the treatment of juvenile rheumatoid arthritis . J Pediatr . 1990;117:645-652.Crossref 13. Simila S, Kouvalainen K, Keinanen S. Oral antipyretic therapy . Scand J Rheumatol . 1976;5:81-83.Crossref 14. Keinanen-Kiukaanniemi S, Simila S, Kouvalainen K. Oral antipyretic therapy evaluation of the propionic acid derivatives ibuprofen, ketoprofen, fenoprofen, and naproxen . Pediatr Padol . 1980;15:239-244. 15. Heremans G, Dehaen F, Rom N, Ramet J, Verboven M. A Single-blind, parallel-group study investigating the antipyretic properties of ibuprofen syrup versus acetylsalicylic acid syrup in febrile children . Br J Clin Pract . 1988;42:245-247. 16. Kandoth PW, Joshi MK, Joshi VR, Satoskar RJ. Comparative evaluation of antipyretic activity of ibuprofen and aspirin in children with pyrexia of varied aetiology . J Int Med Res . 1984;12:292-297. 17. Amdekar YK, Desai RZ. Antipyretic activity of ibuprofen and paracetamol in children with pyrexia . Br J Clin Pract . 1985;39:140-143. 18. Kotob A. A comparative study of two dosage levels of ibuprofen syrup in children with pyrexia . J Int Med Res . 1985;13:122-126. 19. Barbosa MH, Dias PG, Esteves A. Comparative antipyretic study of ibuprofen (suspension) and paracetamol (suppositories) . O Medico . 1983;108:305-307. 20. Phadke MA, Paranjape PV, Joshi AS. Ibuprofen in children with infective disorders: antipyretic efficacy . Br J Clin Pract . 1985;39:437-440. 21. Wilson G, Guerra AJ, Santos NT. Comparative study of the antipyretic effect of ibuprofen (oral suspension) and paracetamol (suppositories) in paediatrics . J Int Med Res . 1984;12:250-254. 22. Walson PD, Galletta G, Braden NJ, Alexander L. Ibuprofen, acetaminophen, and placebo treatment of febrile children . Clin Pharmacol Ther . 1989;46:9-17.Crossref 23. Kauffman RE, Alexander LA, Scheinbaum ML. Ibuprofen suspension in children . Pediatr Res . 1989;25:67A. Abstract. 24. Hall AH, Smolinske SC, Conrad FL, et al. Ibuprofen overdose: 126 cases . Ann Emerg Med . 1986;15:1308-1313.Crossref 25. Temple AR. Pediatric dosing of acetaminophen . Pediatr Pharmacol . 1983;3:321-327. 26. WR Snodgrass. Antipyresis: how about ibuprofen . Pediatr Ther Toxicol . 1989;3:47-48. 27. Walson PD, Galletta G, Chomilo F, Graves P, Alexander L, Scheinbaum ML. Ibuprofen liquid: multidose treatment of febrile children . Eur J Pharmacol . 1989;36( (suppl) ):A154. Abstract. 28. Wilson JT, Brown RD, Bocchini JA, Kearns GL. Efficacy, disposition and pharmacodynamics of aspirin, acetaminophen and choline salicylate in young febrile children . Ther Drug Monit . 1982;4:147-180.Crossref 29. Mazur LJ, Jones TM, Kozinetz CA. Temperature response to acetaminophen and risk of occult bacteremia: a case-control study . J Pediatr . 1989;115:888-891.Crossref

Journal

American Journal of Diseases of Children – American Medical Association

Published: May 1, 1992

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