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Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.

Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model.

Author information

1
Jean Brown Research Inc., Salt Lake City, UT 84049, USA. jbrown@jeanbrownresearch.com

Abstract

OBJECTIVE:

To evaluate the analgesic effects of etoricoxib and comparator agents on the second and third days after oral surgery.

METHODS:

There were 588 patients initially randomized to placebo (n=46), etoricoxib 120 mg once daily (n=97), etoricoxib 90 mg once daily (n=191), ibuprofen 600 mg every 6 hours (n=192), and acetaminophen 600 mg/codeine 60 mg (A/C) every 6 hours (n=62) after third-molar extraction (≥2, ≥1 impacted) in a double-blind controlled trial. Patients were allowed flexible dosing on days 2 and 3; 46, 96, 190, 192, and 56 patients on placebo, etoricoxib 120 mg, etoricoxib 90 mg, ibuprofen, and A/C, respectively, continued to Day 2 of the study. Outcomes included Average and Worst Recall Pain Assessments (0 to 10 scale) and Global Assessments of Study Medication (0 to 4 scale). Rescue medication (acetaminophen 325 mg up to 4 times daily) usage was evaluated. Adverse experiences were collected and evaluated.

RESULTS:

Average Pain Recall scores were lower than placebo for all active treatments on Day 2 but only for etoricoxib 120 and 90 mg on Day 3. Worst Pain Recall scores were lower than placebo for only etoricoxib 120 and 90 mg on Day 2; all treatment groups were similar on day 3. Rescue medicine was used on day 2 in 57% of placebo patients, whereas use in active treatments ranged from 18% to 23%; for Day 3, rescue was used in 22% of placebo patients, whereas use in active treatments ranged from 14% to 20%. Differences in mean Patient's Global Assessment of Study Medication scores were significant for etoricoxib versus placebo (P<0.001) and for etoricoxib versus A/C (P<0.010). Nausea and vomiting were among the most common adverse events with higher frequency in the A/C group.

CONCLUSIONS:

Pain control was most favorable for the etoricoxib doses and ibuprofen. Global Assessments of Study Medication continued to differentiate the treatments and demonstrated greater efficacy for etoricoxib on Days 2 and 3 compared with placebo and A/C (NCT00694369).

PMID:
23247002
DOI:
10.1097/AJP.0b013e318260c144
[Indexed for MEDLINE]
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