Formulations | Primary | PID | PID | PI | PR | GMP/GP | Reference | |||
---|---|---|---|---|---|---|---|---|---|---|
15 | 30 | 45 | 60 | 15 >33% decrease | 30 min | |||||
OTFC Nasal spray | Time to pain relief | 1.7 | 3.4 4.2 p<0.001 | 4.6 4.4 p<0.01 | 22% 54% p<0.001 | 59 | ||||
FPNS Nasal spray | >33% PID | 60 | ||||||||
SLF Placebo | SPID 30 min | 2.2 1.4 | 1.8 1.2 p=0.0002 | 3.1 (PGEM score) 3.6 | 61 | |||||
SLF Placebo | PID 30 min | 22 21 NS VAS mm | 41 34 p=0.002 VAS mm | 56 45 p<0.001 VAS mm | 62 | |||||
SLF IRMS oral | PI | 3 days: 6.0 (SLF) vs 6.9 (M) 30 days: 3.0 (SLF) vs 4.4 (M) p<0.001 | 63 | |||||||
SLF-E Placebo | SPID 30 min | 2.3 1.6 p<0.0001 | 64 | |||||||
OTFC IRMS oral | PID 15 min | 1.8 1.4 p<0.01 | 2.8 2.3 p<0.01 | 3.4 2.9 p<0.01 | 3.9 3.3 p<0.01 | 42% 32% p<0.001 | O<M p<0.05 (no data) | 1.8 1.5 p<0.01 | 2.5 2.1 p<0.001 | 65 |
OTFC Mor IV | 2.8 3.6 p=0.013 | 4.5 5.2 NS | 57% 74% | −41% −52% p=0.026 | 66 | |||||
OTFC Placebo | SPID | 1.45 0.98 p<0.0001 | 1.85 1.19 p<0.0001 | 2.15 1.64 p<0.0001 | 2.28 1.67 p<0.0001 | 1.85 1.19 | 1.98 (30 min) 1.19 p<0.0001 | 67 | ||
Buccal Placebo | SPID 30 min | 0.8 0.5 p<0.0003 | 2.2 1.3 p<0.0001 | 3.3 1.8 p<0.0001 | 3.8 2.1 p<0.0001 | 48% 29% p<0.0001 | 1.3 0.8 p<0.0001 | 1.4 (30 min) 0.9 p<0.0001 | 68 | |
Buccal Placebo | SPID 60 min | 1.4 0.8 p<0.0001 | 2.3 1.2 p<0.0001 | 2.8 1.4 p<0.0001 | 3.2 1.5 p<0.0001 | 51% 26% p<0.0001 | 1.7 1.1 p<0.0001 | 2.1 (60 min) 1.2 p<0.0001 | 69 | |
Buccal Placebo | PID 30 min | 1.2 1.0 NS | 2.3 1.8 p<0.05 | 3.3 2.4 p<0.05 | 60% 42% p<0.05 (60 min) | 2.0 1.5 | 70 | |||
Buccal film Placebo | SPID 30 min | 1.4 1.2 NS | 2.3 1.8 p<0.05 | 2.8 2.2 p<0.01 | 3.2 2.3 p<0.001 | 26% 21% NS | 71 | |||
Nasal spray Placebo | PID 10 min | 2.5 1.3 10 min p<0.001 | 4.2 2.1 40 min p<0.001 | 4.3 2.3 p<0.001 | 80% 45% p<0.001 | 1.9 1.0 p<0.001 | 72 | |||
FPNS IRMS oral | PID 15 min | 3.0 2.7 p<0.05 | 4.1 3.8 p<0.05 | 4.7 4.2 p<0.05 | 5.3 4.8 p<0.01 | 75% 69% (PID >2) at 15 min p<0.05 | 73 | |||
FPNS IRMS oral | No. of patients with benefit at 15 and 30 min | 72% 59% p<0.0005 | 74 | |||||||
FPNS Placebo | SPID 30 min | 2.0 1.3 p<0.001 | 2.7 1.9 p<0.001 | 3.1 1.9 p<0.001 | 3.4 2.0 p<0.001 | 66% 40% (PID >2) | 75 |
FPNS, fentanyl pectin nasal spray; GMP, global medication performance; GP, global performance; IRMS, immediate release morphine sulfate; IV, intravenous; Mor, morphine; Nasal, fentanyl nasal spray; O<M, OTFC lower pain intensity versus IRMS; OTFC, oral transmucosal fentanyl citrate; PGEM score, patients' global evaluation of medication; PI, pain intensity; PID, pain intensity difference; PR, pain relief; SLF, sublingual fentanyl (Abstral); SLF-E, sublingual fentanyl ethypharm (Recivit); SPID, sum of pain intensity differences; VAS, Visual Analogue Scale.