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Acute Pain | Chronic Pain | General

Oral valdecoxib in postoperative pain

Clinical bottom line

Valdecoxib is a highly effective analgesic with an extended duration of action in dental pain. The NNT for one patient to have at least 50% pain relief over four to six hours was 1.7 (1.4 to 2.0) with valdecoxib 20 mg and 1.6 (1.4 to 1.8) with valdecoxib 40 mg. With valdecoxib 20 mg the weighted median time to remedication was greater than 17.5 hours, with valdecoxib 40 mg, greater than 24 hours and with placebo, 1.7 hours.


Reference


J Barden, JE Edwards, HJ McQuay, RA Moore. Oral valdecoxib and injected parecoxib for acute postoperative pain: a quantitative systematic review. BMC Anaesthesiology 2003 3:1


Systematic review

Inclusion criteria were single oral dose, randomised, placebo-controlled, double blind trials of valdecoxib in acute postoperative pain with sufficient data to calculate the area under the curve for pain relief (TOTPAR). Baseline pain was moderate to severe. The 6-hour TOTPAR was calculated for each patient, and the data were converted to the percent of maximum total pain relief from categorical pain scales (%maxTOTPAR), and then to dichotomous information to generate a number-needed-to-treat for at least 50% pain relief. Relative benefit was calculated to provide an assessment of how much more likely an individual given a particular treatment is to have at least 50% pain relief than someone given no treatment. Adverse effects frequency data were used to calculate numbers-needed-to-harm and relative risk.

Results

Two published reports of three trials and one poster were included. All trials were conducted in pain following third molar extraction; there were no significant differences in baseline patient characteristics within or between trials.

EFFICACY (Table 2)

All trials showed statistical benefit of valdecoxib 20 mg and 40 mg over placebo. Overall 69/101 patients (68%) treated with valdecoxib 20 mg experienced at least 50%maxTOTPAR over six hours compared with 8/103 patients (8%) treated with placebo in direct comparisons. The NNT for one patient to have at least half pain relief over six hours was 1.7 (1.4 to 2.0). For valdecoxib 40 mg, 204/279 patients (73%) experienced at least 50% maxTOTPAR over six hours compared to 19/194 patients (10%) with placebo in direct comparisons, the NNT for one patient to have at least half pain relief over six hours with was 1.6 (1.4 to 1.8).

Table 2:



Number (%) of patients with at least 50% pain relief



Drug and dose

Number of trials

Active

Placebo

Relative benefit
(95% CI)


NNT
(95% CI)


Valdecoxib 20 mg
2

69/101
(68)

8/103
(8)

8.8 (4.5 to 17.3)

1.7 (1.4 to 2.0)

Valdecoxib 40 mg
4

204/279
(73)

19/194
(10)

7.3 (4.8 to 11.2)

1.6 (1.4 to 1.8)

 

DURATION OF ANALGESIA

Median time to remedication was reported in three reports. The data from one trial did not permit pooling as the design allowed an additional dose of valdecoxib before patients were classed as having remedicated (Table 1). For placebo, the weighted median time to remedication from 153 patients was 1.7 hours. For valdecoxib 20 mg the weighted median time to remedication based on 101 patients was greater than 17.5 hours. For valdecoxib 40 mg the weighted mean time to remedication based on 199 patients was greater than 24 hours.

ADVERSE EVENTS

No patient was withdrawn as a result of adverse effects. Adverse effect data for the two trials published in one report was already pooled (Table 1). Data from the study with the unconventional remedication regimen were included. Pooled analysis of 324 patients comparing valdecoxib 40 mg to placebo did not reveal any statistically significant differences between valdecoxib and placebo for ‘nausea’, ‘vomiting’, ‘dizziness’, ‘headache’ or ‘any event’. No pooled analysis was possible for valdecoxib 20 mg but the number of patients reporting adverse effects following a single dose was consistently lower than for placebo.

Comment

Valdecoxib is a highly effective oral analgesic with an extended duration of action in dental pain.