A comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients.

BACKGROUND

Pain on injection is a recognized adverse effect of propofol, an agent used to induce general anesthesia in surgical patients. Pretreatment with fentanyl has been reported to be effective in reducing propofol-induced pain.

OBJECTIVE

The aim of this study was to compare the efficacy of intravenous pretreatment with fentanyl 50 microg, fentanyl 100 microg, and lidocaine 40 mg, preceded by venous occlusion, for reducing pain on injection of propofol in adult Japanese surgical patients.

METHODS

This was a prospective, randomized, double-blind, placebo-controlled study. Adult Japanese surgical patients were randomized to 1 of 4 groups to receive intravenous fentanyl 50 microg, fentanyl 100 microg, lidocaine 40 mg, or placebo (0.9% isotonic saline). The drug administration was preceded by manual venous occlusion with a rubber tourniquet for 1 minute, followed by administering propofol 0.5 mg/kg injected into the largest dorsal vein of the hand through a 20-gauge intravenous cannula at the rate of 10 mg/sec. Pain on injection of propofol was assessed by an investigator who was blinded to group assignment. Patients were interviewed to assess pain intensity on injection using a 4-point verbal rating scale (0 = none; 1 = mild; 2 = moderate; and 3 = severe). Incidence and severity of pain were determined in each of the 4 study groups. Adverse events related to the study drug were recorded before the induction of anesthesia and after surgery. Patients were monitored for adverse events for 24 hours following surgery.

RESULTS

A total of 120 patients (70 men and 50 women; mean [SD] age, 44 [11] years; height, 160 [7] cm; weight, 56 [10] kg) completed the study. Each group comprised 30 patients. No significant between-group differences in demographic characteristics were found. The overall incidence of propofol-induced pain was 77% (23/30 patients) with fentanyl 50 microg (P = NS), 37% (11/30 patients) with fentanyl 100 microg (P = 0.001), and 33% (10/30 patients) with lidocaine 40 mg (P = 0.001) compared with 83% (25/30 patients) with placebo. The median pain score was lower in patients who received fentanyl 50 microg (1; P = NS), fentanyl 100 microg (0; P = 0.001), or lidocaine 40 mg (0; P = 0.001) than in those who received placebo (2). The incidence and severity of pain were significantly different between the fentanyl 50-microg and 100-microg groups (incidence, P = 0.002; severity, P = 0.001). However, there was no significant difference in the incidence and severity of such pain between the fentanyl 100-microg and lidocaine 40-mg groups. Both study drugs were well tolerated.

CONCLUSIONS

Preceded by venous occlusion for 1 minute, fentanyl 100 microg was not significantly different from lidocaine 40 mg in reducing pain during injection of propofol in these adult Japanese surgical patients. Fentanyl 50 microg was ineffective in reducing such pain compared with placebo.