Evaluation of the antipyretic effect of ketorolac, acetaminophen, and placebo in endotoxin-induced fever.
J Clin Pharmacol
; 34(8): 848-53, 1994 Aug.
Article
de En
| MEDLINE
| ID: mdl-7962674
ABSTRACT
The authors studied the antipyretic effect of three intramuscular doses of ketorolac (15, 30, and 60 mg), acetaminophen 650 mg PO, and placebo in healthy male volunteers using an endotoxin-induced fever model. In this double-blind, double-dummy, parallel study, subjects were assigned randomly with equal probability to one of the above treatment groups. Thirty minutes after study medication administration, a 20 unit per kilogram dose of reference standard endotoxin (RSE) was administered intravenously, and temperature was determined every 15 minutes for an 8-hour period. Compared with placebo, all active treatment groups demonstrated a statistically significant reduction in both adjusted area under the temperature-by-time curve (AAUC) and the maximum increase over baseline temperature (dTmax). Furthermore, the 30 mg intramuscular dose of ketorolac demonstrated approximately the same antipyretic activity as the 650 mg oral dose of acetaminophen, and there was a statistically significant dose response across the three ketorolac doses studied (P < .0001). The majority of side effects reported during this study were symptoms associated with fever, including chills, headache, myalgia, and dizziness, all of which are effects of RSE. The frequency of side effects tended to be less in the treatment groups with the greatest antipyretic activity.
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Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Tolmétine
/
Anti-inflammatoires non stéroïdiens
/
Analgésiques non narcotiques
/
Endotoxines
/
Fièvre
/
Acétaminophène
Type d'étude:
Clinical_trials
/
Etiology_studies
Limites:
Adolescent
/
Adult
/
Humans
/
Male
/
Middle aged
Langue:
En
Journal:
J Clin Pharmacol
Année:
1994
Type de document:
Article