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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. 2009

Stephen Daniels, and Sandie Reader, and Phillip Berry, and Michael Goulder
Premier Research Group, Clinical Research Center, 3200 Red River, Austin, TX 78705, USA.

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 <or= 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.

UI MeSH Term Description Entries
D007052 Ibuprofen A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties Advil,Benzeneacetic Acid, alpha-methyl-4-(2-methylpropyl)- trimethylsilyl ester,Brufen,Ibumetin,Ibuprofen, (+-)-Isomer,Ibuprofen, (R)-Isomer,Ibuprofen, (S)-Isomer,Ibuprofen, Aluminum Salt,Ibuprofen, Calcium Salt,Ibuprofen, Copper (2+) Salt,Ibuprofen, Magnesium Salt,Ibuprofen, Potassium Salt,Ibuprofen, Sodium Salt,Ibuprofen, Zinc Salt,Ibuprofen-Zinc,Motrin,Nuprin,Rufen,Salprofen,Trauma-Dolgit Gel,alpha-Methyl-4-(2-methylpropyl)benzeneacetic Acid,Ibuprofen Zinc,Trauma Dolgit Gel
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D008964 Molar, Third The aftermost permanent tooth on each side in the maxilla and mandible. Tooth, Wisdom,Teeth, Wisdom,Molars, Third,Third Molar,Third Molars,Wisdom Teeth,Wisdom Tooth
D010147 Pain Measurement Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies. Analgesia Tests,Analogue Pain Scale,Formalin Test,McGill Pain Questionnaire,Nociception Tests,Pain Assessment,Pain Intensity,Pain Severity,Tourniquet Pain Test,Visual Analogue Pain Scale,Analog Pain Scale,Assessment, Pain,McGill Pain Scale,Visual Analog Pain Scale,Analgesia Test,Analog Pain Scales,Analogue Pain Scales,Formalin Tests,Intensity, Pain,Measurement, Pain,Nociception Test,Pain Assessments,Pain Intensities,Pain Measurements,Pain Questionnaire, McGill,Pain Scale, Analog,Pain Scale, Analogue,Pain Scale, McGill,Pain Severities,Pain Test, Tourniquet,Questionnaire, McGill Pain,Scale, Analog Pain,Scale, Analogue Pain,Scale, McGill Pain,Severity, Pain,Test, Analgesia,Test, Formalin,Test, Nociception,Test, Tourniquet Pain,Tests, Nociception,Tourniquet Pain Tests
D010149 Pain, Postoperative Pain during the period after surgery. Acute Post-operative Pain,Acute Postoperative Pain,Chronic Post-operative Pain,Chronic Post-surgical Pain,Chronic Postoperative Pain,Chronic Postsurgical Pain,Pain, Post-operative,Persistent Postsurgical Pain,Post-operative Pain,Post-operative Pain, Acute,Post-operative Pain, Chronic,Post-surgical Pain,Postoperative Pain, Acute,Postoperative Pain, Chronic,Postsurgical Pain,Postoperative Pain,Acute Post operative Pain,Chronic Post operative Pain,Chronic Post surgical Pain,Chronic Postsurgical Pains,Pain, Acute Post-operative,Pain, Acute Postoperative,Pain, Chronic Post-operative,Pain, Chronic Post-surgical,Pain, Chronic Postoperative,Pain, Chronic Postsurgical,Pain, Persistent Postsurgical,Pain, Post operative,Pain, Post-surgical,Pain, Postsurgical,Post operative Pain,Post operative Pain, Acute,Post operative Pain, Chronic,Post surgical Pain,Post-operative Pains,Post-surgical Pain, Chronic,Postsurgical Pain, Chronic,Postsurgical Pain, Persistent
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000082 Acetaminophen Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage. Acetamidophenol,Hydroxyacetanilide,Paracetamol,APAP,Acamol,Acephen,Acetaco,Acetominophen,Algotropyl,Anacin-3,Datril,N-(4-Hydroxyphenyl)acetanilide,N-Acetyl-p-aminophenol,Panadol,Tylenol,p-Acetamidophenol,p-Hydroxyacetanilide,Anacin 3,Anacin3

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