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Onset of analgesia for liquigel ibuprofen 400 mg, acetaminophen 1000 mg, ketoprofen 25 mg, and placebo in the treatment of postoperative dental pain.

Abstract

Ibuprofen is a peripherally acting nonsteroidal anti-inflammatory drug indicated fo ranalgesia, antipyresis, and various arthritic conditions. A solubilized 200 mg liquigel formulation of ibuprofen has been shown to have a more rapid rate of absorption compared with ibuprofen 200 mg tablets. Ibuprofen liquigels have a kinetic profile similar to ibuprofen suspension, with both a higher Cmax and an earlier tmax than any solid tablet. The objective of this single-dose, double-blind, triple-dummy, parallel-group study was to assess the time to onset of relief and overall analgesic efficacy of liquigel ibuprofen 400 mg, ketoprofen 25 mg compared with acetaminophen 1000 mg, and placebo in 239 patients with moderate or severe pain following third molar extractions. Treatments were compared over 6 hours using standard scales for pain intensity and relief and stopwatch onset of meaningful relief. All active treatments provided meaningful relief significantly faster compared with placebo. Ibuprofen provided significantly faster relief compared with acetaminophen and ketoprofen. By the end of the study (6 h), onset of meaningful relief was achieved by 36%, 99%, 96%, and 88% of the patients in the placebo, ketoprofen, ibuprofen, and acetaminophen groups, respectively. The median times to onset of relief were > 6 hours for placebo, 25.5 minutes for ketoprofen, 24.2 minutes for ibuprofen, and 29.9 minutes for acetaminophen. In addition, both ibuprofen and ketoprofen showed statistical superiority over acetaminophen at earlier time points on the time-effect curves for pain relief and pain intensity difference. Consistent results were seen with respect to the 6-hour summary efficacy variables: the three active treatments were significantly better than placebo, and ibuprofen was significantly better than both acetaminophen and ketoprofen. Liquigel ibuprofen 400 mg was shown to provide faster relief and superior overall efficacy compared with ketoprofen 25 mg, acetaminophen 1000 mg, and placebo. No serious adverse effects were reported in this single-dose study.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Analgesic Development, Ltd, New York NY 10022-1009, USA.

    , , , , , ,

    Source

    Journal of clinical pharmacology 41:11 2001 Nov pg 1238-47

    MeSH

    Abdominal Pain
    Acetaminophen
    Adolescent
    Adult
    Aged
    Analgesics, Non-Narcotic
    Anti-Inflammatory Agents, Non-Steroidal
    Double-Blind Method
    Female
    Gels
    Headache
    Humans
    Ibuprofen
    Ketoprofen
    Male
    Middle Aged
    Pain Measurement
    Pain, Postoperative
    Time Factors
    Tooth Extraction
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    11697757

    Citation

    Olson, N Z., et al. "Onset of Analgesia for Liquigel Ibuprofen 400 Mg, Acetaminophen 1000 Mg, Ketoprofen 25 Mg, and Placebo in the Treatment of Postoperative Dental Pain." Journal of Clinical Pharmacology, vol. 41, no. 11, 2001, pp. 1238-47.
    Olson NZ, Otero AM, Marrero I, et al. Onset of analgesia for liquigel ibuprofen 400 mg, acetaminophen 1000 mg, ketoprofen 25 mg, and placebo in the treatment of postoperative dental pain. J Clin Pharmacol. 2001;41(11):1238-47.
    Olson, N. Z., Otero, A. M., Marrero, I., Tirado, S., Cooper, S., Doyle, G., ... Sunshine, A. (2001). Onset of analgesia for liquigel ibuprofen 400 mg, acetaminophen 1000 mg, ketoprofen 25 mg, and placebo in the treatment of postoperative dental pain. Journal of Clinical Pharmacology, 41(11), pp. 1238-47.
    Olson NZ, et al. Onset of Analgesia for Liquigel Ibuprofen 400 Mg, Acetaminophen 1000 Mg, Ketoprofen 25 Mg, and Placebo in the Treatment of Postoperative Dental Pain. J Clin Pharmacol. 2001;41(11):1238-47. PubMed PMID: 11697757.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Onset of analgesia for liquigel ibuprofen 400 mg, acetaminophen 1000 mg, ketoprofen 25 mg, and placebo in the treatment of postoperative dental pain. AU - Olson,N Z, AU - Otero,A M, AU - Marrero,I, AU - Tirado,S, AU - Cooper,S, AU - Doyle,G, AU - Jayawardena,S, AU - Sunshine,A, PY - 2001/11/8/pubmed PY - 2002/4/16/medline PY - 2001/11/8/entrez SP - 1238 EP - 47 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 41 IS - 11 N2 - Ibuprofen is a peripherally acting nonsteroidal anti-inflammatory drug indicated fo ranalgesia, antipyresis, and various arthritic conditions. A solubilized 200 mg liquigel formulation of ibuprofen has been shown to have a more rapid rate of absorption compared with ibuprofen 200 mg tablets. Ibuprofen liquigels have a kinetic profile similar to ibuprofen suspension, with both a higher Cmax and an earlier tmax than any solid tablet. The objective of this single-dose, double-blind, triple-dummy, parallel-group study was to assess the time to onset of relief and overall analgesic efficacy of liquigel ibuprofen 400 mg, ketoprofen 25 mg compared with acetaminophen 1000 mg, and placebo in 239 patients with moderate or severe pain following third molar extractions. Treatments were compared over 6 hours using standard scales for pain intensity and relief and stopwatch onset of meaningful relief. All active treatments provided meaningful relief significantly faster compared with placebo. Ibuprofen provided significantly faster relief compared with acetaminophen and ketoprofen. By the end of the study (6 h), onset of meaningful relief was achieved by 36%, 99%, 96%, and 88% of the patients in the placebo, ketoprofen, ibuprofen, and acetaminophen groups, respectively. The median times to onset of relief were > 6 hours for placebo, 25.5 minutes for ketoprofen, 24.2 minutes for ibuprofen, and 29.9 minutes for acetaminophen. In addition, both ibuprofen and ketoprofen showed statistical superiority over acetaminophen at earlier time points on the time-effect curves for pain relief and pain intensity difference. Consistent results were seen with respect to the 6-hour summary efficacy variables: the three active treatments were significantly better than placebo, and ibuprofen was significantly better than both acetaminophen and ketoprofen. Liquigel ibuprofen 400 mg was shown to provide faster relief and superior overall efficacy compared with ketoprofen 25 mg, acetaminophen 1000 mg, and placebo. No serious adverse effects were reported in this single-dose study. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/11697757/Onset_of_analgesia_for_liquigel_ibuprofen_400_mg_acetaminophen_1000_mg_ketoprofen_25_mg_and_placebo_in_the_treatment_of_postoperative_dental_pain_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0091-2700&date=2001&volume=41&issue=11&spage=1238 DB - PRIME DP - Unbound Medicine ER -