Abstract
This randomized, double-blind, placebo-controlled study evaluated the antipyretic effect and safety of intravenous (i.v.) acetaminophen using an endotoxin-induced fever model. Subjects exhibiting sufficient fever response following administration of reference standard endotoxin (RSE) were randomly assigned to receive i.v. acetaminophen 1,000mg (n = 31) or matching placebo (n = 29). The primary efficacy end point was the weighted sum of temperature differences from baseline through 6h. Relative to placebo, i.v. acetaminophen administration produced a rapid decrease in temperature that persisted throughout the 6-h study period. The primary end point favored i.v. acetaminophen over placebo (P 0.001). Temperature differences from baseline reached statistical significance at T30min after endotoxin administration (15min after completing the study medication infusion). Acetaminophen administered i.v. was well tolerated, and the frequency of adverse events was comparable to that after administration of i.v. placebo. This study shows that i.v. acetaminophen in a single 1,000-mg dose is safe and effective in reducing fever.
| Original language | English |
|---|---|
| Pages (from-to) | 32-39 |
| Number of pages | 8 |
| Journal | Clinical Pharmacology and Therapeutics |
| Volume | 90 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jul 1 2011 |
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ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
Cite this
A randomized study of the efficacy and safety of intravenous acetaminophen vs. Intravenous placebo for the treatment of fever. / Kett, Daniel H; Breitmeyer, J. B.; Ang, R.; Royal, M. A.
In: Clinical Pharmacology and Therapeutics, Vol. 90, No. 1, 01.07.2011, p. 32-39.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized study of the efficacy and safety of intravenous acetaminophen vs. Intravenous placebo for the treatment of fever
AU - Kett, Daniel H
AU - Breitmeyer, J. B.
AU - Ang, R.
AU - Royal, M. A.
PY - 2011/7/1
Y1 - 2011/7/1
N2 - This randomized, double-blind, placebo-controlled study evaluated the antipyretic effect and safety of intravenous (i.v.) acetaminophen using an endotoxin-induced fever model. Subjects exhibiting sufficient fever response following administration of reference standard endotoxin (RSE) were randomly assigned to receive i.v. acetaminophen 1,000mg (n = 31) or matching placebo (n = 29). The primary efficacy end point was the weighted sum of temperature differences from baseline through 6h. Relative to placebo, i.v. acetaminophen administration produced a rapid decrease in temperature that persisted throughout the 6-h study period. The primary end point favored i.v. acetaminophen over placebo (P 0.001). Temperature differences from baseline reached statistical significance at T30min after endotoxin administration (15min after completing the study medication infusion). Acetaminophen administered i.v. was well tolerated, and the frequency of adverse events was comparable to that after administration of i.v. placebo. This study shows that i.v. acetaminophen in a single 1,000-mg dose is safe and effective in reducing fever.
AB - This randomized, double-blind, placebo-controlled study evaluated the antipyretic effect and safety of intravenous (i.v.) acetaminophen using an endotoxin-induced fever model. Subjects exhibiting sufficient fever response following administration of reference standard endotoxin (RSE) were randomly assigned to receive i.v. acetaminophen 1,000mg (n = 31) or matching placebo (n = 29). The primary efficacy end point was the weighted sum of temperature differences from baseline through 6h. Relative to placebo, i.v. acetaminophen administration produced a rapid decrease in temperature that persisted throughout the 6-h study period. The primary end point favored i.v. acetaminophen over placebo (P 0.001). Temperature differences from baseline reached statistical significance at T30min after endotoxin administration (15min after completing the study medication infusion). Acetaminophen administered i.v. was well tolerated, and the frequency of adverse events was comparable to that after administration of i.v. placebo. This study shows that i.v. acetaminophen in a single 1,000-mg dose is safe and effective in reducing fever.
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U2 - 10.1038/clpt.2011.98
DO - 10.1038/clpt.2011.98
M3 - Article
C2 - 21544074
AN - SCOPUS:79959373438
VL - 90
SP - 32
EP - 39
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
SN - 0009-9236
IS - 1
ER -