A randomized, double-blind crossover trial of paracetamol 1000 mg four times daily vs ibuprofen 600 mg: effect on swelling and other postoperative events after third molar surgery

Abstract

Aims: To evaluate the effect of a 3-day regimen of ibuprofen 600 mg x 4 on acute postoperative swelling and pain and other inflammatory events after third molar surgery compared with a traditional regimen of paracetamol 1000 mg x 4.

Methods: A controlled, randomized, double-blind, cross-over study where 36 patients (26 females, 10 males) with mean age 23 (range 19-27) years acted as their own controls. All patients were subjected to surgical removal of bilateral third molars. After one operation the patients received tablets of ibuprofen 600 mg x 4 for 3 days. After the other operation they received an identical regimen of paracetamol 1000 mg tablets. Swelling was objectively measured (mm) with a standardized face bow and the patients scored their pain intensity (PI) on a 100-mm visual analogue scale.

Results: There was no statistically significant difference between paracetamol and ibuprofen treatment with respect to effect on acute postoperative swelling. Swelling after paracetamol on the third postoperative day was 1.8% less than that after ibuprofen. Mean (95% CI) difference between treatments was -0.3 (-4.7, 4.1) mm. On the sixth postoperative day swelling after ibuprofen was 2.3% less than that after paracetamol. Mean (95% CI) between treatments was 0.2 (-2.4, 2.8) mm. There was no statistically significant difference in pain intensity between the paracetamol and the ibuprofen regimen on the day of surgery. The mean (95% CI) difference between the treatments for summed pain intensity on the day of surgery (SUMPI 3.5-11) was 3.31 (-47.7, 54.3) mm. Two patients developed fibrinolysis of the blood clot (dry socket) after receiving ibuprofen while none did this after paracetamol treatment. There was no noticeable difference between treatments with respect to appearance of haematomas/ecchymoses or adverse effects which all were classified as mild to moderate.

Conclusions: A 3-day regimen of ibuprofen 600 mg x 4 daily does not offer any clinical advantages compared with a traditional paracetamol regimen 1000 mg x 4 daily with respect to alleviation of acute postoperative swelling and pain after third molar surgery.

Figure 1

Orthopantomograms showing the position of bilateral impacted third molars in the lower jaw.

Figure 2

Measurement of the left lateral facial contour adjacent to the surgical site before third molar surgery. Changes in the distance between the facial soft tissue contour adjacent to the surgical site and the face-bow are measured by eight adjustable pins.

Figure 3

The mean pain intensity scores assessed on the day of surgery by 36 patients who had bilaterally impacted third molars removed on two separate occasions. On one occasion they received paracetamol (•) 1000 mg × 4 for 3 days. On the other occasion they received ibuprofen (○) 600 mg × 4 for the same time period.

Figure 4

The mean pain intensity scores assessed on the first to the fourth postoperative day by 36 patients who had bilaterally impacted third molars removed on two separate occasions. On one occasion they received paracetamol (•) 1000 mg × 4 for 3 days. On the other occasion they received ibuprofen (○) 600 mg × 4 for the same time period.