A randomised, five-parallel-group, placebo-controlled trial comparing the efficacy and tolerability of analgesic combinations including a novel single-tablet combination of ibuprofen/paracetamol for postoperative dental pain.
Combination analgesia is often recommended for the relief of severe pain. This was a double-blind, 5-arm, parallel-group, placebo-controlled, randomised, single-dose study designed to compare the efficacy and tolerability of a novel single-tablet combination of ibuprofen and paracetamol with that of an ibuprofen/codeine combination, and a paracetamol/codeine combination, using the dental impaction pain model. Subjects with at least 3 impacted third molars and experiencing moderate to severe postoperative pain were randomised to receive: 1 or 2 tablets of a single-tablet combination of ibuprofen 200mg/paracetamol 500mg; 2 tablets of ibuprofen 200 mg/codeine 12.8mg; 2 tablets of paracetamol 500mg/codeine 15mg; or placebo. Results for the primary endpoint, the sum of the mean scores of pain relief combined with pain intensity differences over 12hours, demonstrated that 1 and 2 tablets of the single-tablet combination of ibuprofen/paracetamol were statistically significantly more efficacious than 2 tablets of placebo (P<0.0001) and paracetamol/codeine (P⩽0.0001); furthermore, 2 tablets offered significantly superior pain relief to ibuprofen/codeine (P=0.0001), and 1 tablet was found noninferior to this combination. Adverse events were uncommon during this study and treatment emergent adverse events were statistically significantly less frequent in the groups taking the ibuprofen/paracetamol combination compared with codeine combinations. In conclusion, 1 or 2 tablets of a single-tablet combination of ibuprofen 200mg/paracetamol 500mg provided highly effective analgesia that was comparable with, or superior to, other combination analgesics currently indicated for strong pain. A single-tablet combination of ibuprofen 200mg/paracetamol 500mg provides highly effective analgesia, comparable or superior to other combination analgesics indicated for strong pain.
Premier Research, Austin, TX, USA Worldwide Clinical Trials, Nottingham, UK Reckitt Benckiser Healthcare UK Ltd, Hull, UK Clearcut Clinical Consulting, Nottingham, UK.
Stephen E
SE
Daniels
Michael A
MA
Goulder
Sue
S
Aspley
Sandie
S
Reader
D000082:Acetaminophen / Q000627:therapeutic use*; D000293:Adolescent; D000700:Analgesics / Q000627:therapeutic use*; D057973:Dent Disease / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008297:Male; D010147:Pain Measurement / Q000379:methods; D010149:Postoperative Pain / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D055815:Young Adult
D000700:Analgesics; D000082:Acetaminophen; D007052:Ibuprofen
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