Skip to main content

Advertisement

SpringerLink
Log in

Onset of analgesia with sodium ibuprofen, ibuprofen acid incorporating poloxamer and acetaminophen—a single-dose, double-blind, placebo-controlled study in patients with post-operative dental pain

  • Clinical Trial
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Objective

To compare the onset of action and efficacy of sodium ibuprofen (ibuprofen sodium dihydrate) and ibuprofen acid incorporating poloxamer (ibuprofen/poloxamer) with that of acetaminophen and placebo in patients with post-operative dental pain.

Methods

A double-blind, randomised, placebo-controlled, active comparator, two-centre study assessing the analgesic efficacy of sodium ibuprofen (512 mg, equivalent to 400 mg ibuprofen acid), ibuprofen/poloxamer (containing 400 mg ibuprofen acid and 120 mg poloxamer 407), acetaminophen (1000 mg) and placebo in patients with moderate-to-severe pain after third molar extraction (n = 322). Onset of action was assessed using the two-stopwatch technique, and pain intensity and relief were measured using validated traditional descriptor scales.

Results

Significantly more patients achieved confirmed perceptible pain relief and meaningful pain relief with sodium ibuprofen (96.3%, P < 0.0001) and ibuprofen/poloxamer (90.0%, P = 0.0005) than with acetaminophen (67.5%). The onset of action of both ibuprofen formulations was comparable with that of acetaminophen up to 45 min post-dose; a marked divergence in onset times in favour of the ibuprofen formulations occurred from 45 min onward. Mean values for the area under the pain relief and pain intensity differences curve (0–6 h) were significantly greater for sodium ibuprofen (3.46) and ibuprofen acid (3.49) than for acetaminophen (2.25) (P < 0.001). Other pain relief and pain intensity endpoints favoured both ibuprofen formulations over acetaminophen. Distractibility from pain (6 h) was significantly greater with the ibuprofen formulations than with acetaminophen (P = 0.008 for sodium ibuprofen; P = 0.03 for ibuprofen/poloxamer). In patients receiving ibuprofen, pain interfered less with daily activities (at 1 and 6 h) than in those receiving acetaminophen (P ≤ 0.015). Both ibuprofen formulations had significantly better mean global assessment scores than acetaminophen (P < 0.001). Tolerability profiles of the ibuprofen formulations were comparable with that of acetaminophen.

Conclusions

Compared with acetaminophen, sodium ibuprofen was associated with significantly greater analgesic efficacy, pain relief in a greater proportion of patients and greater patient satisfaction.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Sweetman SC (ed) (2002) Ibuprofen. In: Martindale: the complete drug reference, 33rd edn. Pharmaceutical Press, London

  2. Mehlisch DR, Sollecito WA, Helfrick JF et al (1990) Multicenter clinical trial of ibuprofen and acetaminophen in the treatment of postoperative dental pain. J Am Dent Assoc 121:257–263

    PubMed  CAS  Google Scholar 

  3. Roy S (1983) A double-blind comparison of propionic acid derivative (ibuprofen) and a fenamate (mefanamic acid) in the treatment of dysmenorrhoea. Obstet Gynecol 61:628–632

    PubMed  CAS  Google Scholar 

  4. Moran M (1991) Double-blind comparison of diclofenac potassium, ibuprofen and placebo in the treatment of ankle sprain. J Int Med Res 19:121–130

    PubMed  CAS  Google Scholar 

  5. Goswick CB (1983) Ibuprofen versus propoxyphene hydrochloride and placebo in acute musculoskeletal trauma. Curr Ther Res Clin Exp 34:685–692

    Google Scholar 

  6. Schachtel BP, Thoden WR (1988) Onset of action of ibuprofen in the treatment of muscle-contraction headache. Headache 28:471–474

    Article  PubMed  CAS  Google Scholar 

  7. Pearce I, Frank GJ, Pearce JMS (1983) Ibuprofen compared with acetaminophen in migraine. Practitioner 227:465–467

    PubMed  CAS  Google Scholar 

  8. Dewland P, Reader S, Berry P (2008) Bioavailability of ibuprofen following oral administration of standard ibuprofen, sodium ibuprofen or ibuprofen acid incorporating poloxamer in healthy volunteers. Eur J Clin Pharmacol (submitted)

  9. Geisslinger G, Menzel S, Wissel K, Brune K (1993) Single dose pharmacokinetics of different formulations of ibuprofen and aspirin. Drug Invest 5:238–242

    CAS  Google Scholar 

  10. Schleier P, Prochnau A, Schmidt-Westhausen AM et al (2007) Ibuprofen sodium dihydrate, an ibuprofen formulation with improved absorption characteristics, provides faster and greater pain relief than ibuprofen acid. Int J Clin Pharmacol Ther 45:89–97

    PubMed  CAS  Google Scholar 

  11. Black P, Max MB, Desjardins P et al (2002) A randomized, double-blind, placebo-controlled comparison of the analgesic efficacy, onset of action, and tolerability of ibuprofen arginate and ibuprofen in postoperative dental pain. Clin Ther 24:1072–1089

    Article  PubMed  CAS  Google Scholar 

  12. Desjardins P, Black P, Papageorge M et al (2002) Ibuprofen arginate provides effective relief from postoperative dental pain with a more rapid onset of action than ibuprofen. Eur J Clin Pharmacol 58:387–394

    Article  PubMed  CAS  Google Scholar 

  13. Albert KS, Gernaat CM (1984) Pharmacokinetics of ibuprofen. Am J Med 77:40–46

    PubMed  CAS  Google Scholar 

  14. Davies NM (1998) Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet 34:101–114

    Article  PubMed  CAS  Google Scholar 

  15. Cooper SA, Precheur H, Rauch D et al (1984) The analgesic efficacy of ibuprofen compared to acetaminophen with codeine (abstract). Clin Pharmacol Ther 35:232

    Google Scholar 

  16. Mehlisch D, Frakes L (1984) A controlled comparative evaluation of acetaminophen and aspirin in the treatment of post-operative pain. Clin Ther Exerpta Med 7:89–97

    CAS  Google Scholar 

  17. Mehlisch D, Markenson J Schnitzer T (1999) The efficacy of nonsteroidal anti-inflammatory drugs for acute pain. Cancer Control 6:5–9

    PubMed  Google Scholar 

  18. Daniels SE, Desjardins PJ, Talwalker S et al (2002) The analgesic efficacy of valdecoxib vs. oxycodone/acetaminophen after oral surgery. J Am Dental Assoc 133:611–621

    CAS  Google Scholar 

  19. Mehlisch DR, Ardia A, Pallotta T (2002) A controlled comparative study of ibuprofen arginate versus conventional ibuprofen in the treatment of postoperative dental pain. J Clin Pharmacol 42:904–911

    Article  PubMed  CAS  Google Scholar 

  20. World Medical Association (1964) Declaration of Helsinki: Ethical principles for medical research involving human patients. Adopted by the 18th WMA General Assembly 1964 and amended by the 29th, 35th, 41st and 48th WMA General Assemblies

  21. European Parliament and Council of 4 April 2001 (2001) Directive 2001/20/EC of the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the European Communities, Brussels

  22. Mehlisch DR, Jasper RD, Brown P et al (1995) Comparative study of ibuprofen lysine and acetaminophen in patients with postoperative dental pain. Clin Ther 17:852–860

    Article  PubMed  CAS  Google Scholar 

  23. Olson NZ, Otero AM, Marrero I et al (2001) 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 41:1238–1247

    Article  PubMed  CAS  Google Scholar 

  24. Sachs C (2005) Oral analgesics for acute nonspecific pain. Am Fam Physician 71:913–918

    PubMed  Google Scholar 

  25. Doyle G, Furey S, Berlin R et al (1999) Gastrointestinal safety and tolerance of ibuprofen at maximum over-the-counter dose. Aliment Pharmacol Ther 13:897–906

    Article  PubMed  CAS  Google Scholar 

  26. Henry D, Lim LL, Garcia Rodriguez LA et al (1996) Variability in risk of gastrointestinal complications with individual non-steroidal anti-inflammatory drugs: results of collaborative met-analysis. Br Med J 312:1563–1566

    CAS  Google Scholar 

  27. Henry D, McGettigan P (2003) Epidemiology overview of gastrointestinal and renal toxicity of NSAIDs. Int J Clin Pract 135:43–49

    Google Scholar 

Download references

Acknowledgements

The authors would like to acknowledge Franklin S. Bonasso, DDS and R. Dean Jasper, DDS (Central Oral Surgery Group), Barbara Hernandez, MA, CCRC, Michael Goulder (Worldwide Clinical Trials UK Ltd) for statistical support, and Vandana Sahajpal, PhD and Quyen Chu, PhD (Sudler & Hennessey, London) for medical writing support.

Conflict of interest

This study was funded by Reckitt Benckiser Group plc. Stephen Daniels (Premier Research Group, Clinical Research Centers, USA) is the Co-ordinating Investigator. Sandie Reader and Phillip Berry are employees of Reckitt Benckiser Group plc.

Author information

Authors and Affiliations

  1. Premier Research Group, Clinical Research Center, 3200 Red River, Austin, TX, 78705, USA

    Stephen Daniels

  2. Reckitt Benckiser Healthcare UK, Dansom Lane, Hull, HU8 7DS, UK

    Sandie Reader & Phillip Berry

  3. Worldwide Clinical Trials UK Ltd, Isaac Newton Centre, Nottingham Science and Technology Park, Nottingham, NG7 2RH, UK

    Michael Goulder

Authors
  1. Stephen Daniels
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Sandie Reader
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Phillip Berry
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Michael Goulder
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Phillip Berry.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Daniels, S., Reader, S., Berry, P. et al. Onset of analgesia with sodium ibuprofen, ibuprofen acid incorporating poloxamer and acetaminophen—a single-dose, double-blind, placebo-controlled study in patients with post-operative dental pain. Eur J Clin Pharmacol 65, 343–353 (2009). https://doi.org/10.1007/s00228-009-0614-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-009-0614-y

Keywords

Search

Navigation