Study identification | Minkowitz et al18 | Singla et al17 | Jove et al21 | Ringold et al19 | Minkowitz et al20 | Melson et al22 |
Year | 2013 | 2014 | 2015 | 2015 | 2017 | 2014 |
Type of surgery | KR and ABS | Bunionectomy | K/HR | ABS | ABS | All patients |
Randomisation | Yes | Yes | Yes | Yes | Yes | Yes |
Blinding | Yes | Yes | Yes | Yes | Yes | Yes |
Study population | SSTS: 127 Placebo: 54 | SSTS: 80 Placebo: 20 | SSTS: 315 Placebo: 104 | SSTS: 115 Placebo: 57 | SSTS: 107 Placebo: 54 | SSTS: 177 Intravenous PCA: 180 |
Strength of SST per dose | KR: 5, 10, 15 μg | 20 and 30 μg | 15 μg | 15 μg | 15 μg | 15 μg |
ABS: 10, 15 μg | ||||||
SPID Mean (SD) SSTS vs placebo | KR*: 18 (17.88) vs 2 (19.59) | 6.53 (16.14) vs −7.12 (23.02)† | 76 (124.2) vs −11 (112.17) | 105.6 (108.7) vs 55.5 (98.9) | 25.8 (17.68) vs 13.1 (17.26) | 77.94 (111.7) vs 72.33 (107.7) |
ABS*: 28 (16.15) vs 11 (16.43) | ||||||
Rescue medication, mean number of doses (SD)* | NM | 1.1 (0.9) vs 2.1 (0.7)‡ | NM | 1.9 vs 4.0§ | NM | NM |
Discontinuation due to inadequate analgesia, SSTS vs placebo, n (%) | KR: 5 (25) vs 16 (67) | NM | 14% vs 48% | 17.4% vs 31.6% | 10 (18.5) vs 4 (3.7) | 13 (7.3) vs 16 (8.9) |
ABS: 3 (10) vs 21 (71) |
*15 μg group.
†30 μg group,
‡Rescue medication: oral Vicodin.
§Intravenous morphine: one oral Vicodin tablet (5 mg hydrocodone/500 mg acetaminophen) was allowed 10 min after administration of a dose of study drug but not within the first hour of the study and not more frequently than every 4 hours; 2 mg intravenous morphine; morphine dosing was allowed after only 10 min had passed following study drug dosing and not more than once per hour throughout the study.
ABS, abdominal surgery; HR, hip replacement; KR, knee replacement; NM, not mentioned; PCA, patient-controlled analgesia; SPID, time-weighted summed pain intensity difference from baseline; SST, sufentanil sublingual tablet; SSTS, sufentanil sublingual tablet system.