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Acute Pain | Chronic Pain | General

Oral ketorolac for postoperative pain

Clinical bottom line:

Ketorolac is an effective analgesic. A single dose of oral ketorolac 10 mg had an NNT of 2.6 (2.3 to 3.1). for at least 50% pain relief over 4-6 hours in patients with moderate or severe pain compared with placebo. This is more effective than a 1000 mg dose of paracetamol which has an NNT of 4.6 (3.9-5.4).

Based on very small amounts of data, 20 mg of oral ketorolac provides effective pain relief with an NNT of 1.8 (1.4 to 2.5), but 5 mg does not. These findings should be interpreted with caution.

Adverse effects were mainly drowsiness or somnolence, dizziness or lightheadedness, nausea or vomiting and dry mouth.

Ketorolac for pain relief

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) which is licensed for short term use in the management of moderate to severe postoperative pain.

Systematic review

Smith LA, Carroll D, Edwards JE, Moore RA, McQuay HJ. Single dose ketorolac and pethidine in acute postoperative pain: a systematic review. (Unpublished).

Inclusion criteria were randomised, double-blind, placebo controlled trials of oral ketorolac in postoperative pain; adult patients; baseline pain of moderate to severe intensity; oral and/or intramuscular administration; pain outcome at least four hours.

Mean TOTPAR and SPID values for each trial were converted to %maxTOTPAR and %maxSPID, and then the proportion of patients achieving at least 50%maxTOTPAR were calculated. This information was used to calculate numbers-needed-to-treat and relative benefit. Adverse effects frequency data were used to calculate numbers-needed-to-harm and relative risk.

Findings

Ketorolac 10 mg oral

Eight trials in 790 patients were included. Ketorolac was significantly more effective than placebo, with an NNT of 2.6 (2.3 to 3.1).

Ketorolac 5 mg oral

One trial with 60 patients was included. There was no difference between ketorolac 5 mg and placebo, relative risk 1.2 (0.8 to 1.8).

Ketorolac 20 mg oral

One trial with 69 patients was included. Ketorolac was significantly more effective than placebo, with an NNT of 1.8 (1.4 to 2.5).

Table: Summary of relative benefit and number-needed-to-treat for at least 50% pain relief in trials of oral ketorolac compared with placebo

Dose Route Number of trials Ketorolac At least 50% pain relief Number/Total Placebo At least 50% pain relief Number/Total Relative Benefit (95% CI) NNT (95%CI)
5 mg oral 1 21/30 17/30 1.2 (0.8 to 1.8) nc
10 mg oral 8 205/410 43/380 4.3 (3.2 to 5.8) 2.6 (2.3 to 3.1)
20 mg oral 1 20/35 0/34 39 (2.5 to 632) 1.8 (1.4 to 2.5)
RB relative benefit; NNT number-needed-to-treat; nc not calculated because relative benefit not statistically significant

Adverse effects

Data were available for 10 mg doses only. Based on five trials there were significantly more adverse effects with ketorolac compared with placebo, NNH 7.3 (4.7 to 17). These were mainly drowsiness or somnolence, dizziness or lightheadedness, nausea or vomiting and dry mouth. Three patients taking ketorolac withdrew due to adverse effects compared with one on placebo.

Note: Ketorolac is associated in reports from Italy with high rates of severe gastric intestinal complications.

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