A randomized, double-masked, clinical study of the efficacy of four nonsteroidal anti-inflammatory drugs in pain control after excimer laser photorefractive keratectomy.

Abstract

OBJECTIVE:

This study assessed the efficacy of 4 nonsteroidal anti-inflammatory drugs (NSAIDs) after excimer laser photorefractive keratectomy (PRK).

BACKGROUND:

Inadequate control of pain after PRK surgery can be a severe source of distress to patients and can interfere with their willingness to undergo a second PRK procedure.

METHODS:

This randomized, double-masked, placebo-controlled clinical study was conducted in 125 patients. Four NSAIDs (diclofenac, flurbiprofen, ketorolac, and indomethacin) were tested against a placebo group (artificial tears). Pain levels after PRK were quantified using Present Pain Intensity (PPI) and Pain Rating Indices based on rank values (PRI[R]) scores, both of which were calculated using patient responses to a modified McGill Pain Questionnaire. The PRI(R) consisted of 4 subscales-sensory (S), affective (A), evaluative (E), and miscellaneous (M)-as well as a total score (T).

RESULTS:

Three hours after PRK, no differences in PPI scores were found between the ketorolac, diclofenac, and indomethacin groups, whereas placebo was significantly less effective than the NSAIDs. Patients who received flurbiprofen reported PPI scores that were significantly lower (P < 0.001) than those of patients who received diclofenac and indomethacin, but PPI scores in the flurbiprofen and the ketorolac groups did not differ significantly. Twenty-four hours after surgery, patients treated with flurbiprofen, ketorolac, and diclofenac reported the lowest PPI scores compared with those treated with indomethacin and placebo (P < 0.001). Moreover, flurbiprofen-treated patients also had the lowest PRI(R)T scores (P < 0.001). When the pain rating index was examined by subclass, a significantly lower PRI(R)S score was detected in the flurbiprofen group at 24 hours (P < 0.001). The PRI(R)A score was significantly higher in the placebo and indomethacin groups compared with the other groups (P < 0.001). At the 48- and 72-hour time points, flurbiprofen-treated patients again reported significantly lower PPI and PRI(R)T scores (P < 0.001 for both) in pair-wise comparisons with the other treatment groups. The number of patients who self-administered additional oral analgesics did not differ significantly between the groups. However, the mean number of analgesic tablets used was significantly higher in the placebo group than in any NSAID group (P < 0.001). The ketorolac group had the largest number of patients complaining of itching (P < 0.043). No other subjective symptoms were significantly different across groups. Finally, all NSAIDs, except flurbiprofen, prolonged the mean reepithelialization period slightly (P < 0.001).

CONCLUSIONS:

Flurbiprofen appeared to be the most effective NSAID for the treatment of pain, even at 24 hours after surgery when pain was at a maximum.

• Authors: M Vetrugno, A Maineo, G M Quaranta, L Cardia
• Journal: Clinical therapeutics (Clin Ther) Vol. 22 Issue 6 Pg. 719-31 (Jun 2000) ISSN: 0149-2918 [Print] United States
• PMID: 10929919 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Placebos

Topics

• Anti-Inflammatory Agents, Non-Steroidal (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Lasers, Excimer
• Male
• Photorefractive Keratectomy (adverse effects)
• Placebos
• Prospective Studies