Table 1 Patient Characteristics by Cohort (Full Analysis Set)
Characteristic | Methoxyflurane Cohort (N = 1236) | Concurrent Cohort (N = 1101) | Non-concurrent Cohort (N = 45112) |
|---|---|---|---|
Age (years) | |||
Mean (SD) | 46.0 (17.80) | 46.5 (19.68) | 50.9 (21.10) |
Median (range) | 45.0 (18–93) | 44.0 (18–97) | 50.0 (18–112) |
> 75 [n (%)] | 80 (6.47) | 118 (10.72) | 7129 (15.80) |
Gender [n (%)] | |||
Female | 550 (44.50) | 505 (45.87) | 23633 (52.39) |
Medical history, [n (%)] | |||
Genetically susceptible to malignant hyperthermia | 2 (0.16) | 1 (0.09) | NC |
History of severe adverse reactions | 38 (3.07) | 51 (4.63) | NC |
History of drug abuse | 21 (1.70) | 19 (1.73) | 182 (0.40) |
History of alcohol abuse | 29 (2.35) | 34 (3.09) | 933 (2.07) |
Comorbidities in 12 weeks before index date, [n (%)] | |||
Viral hepatitis | 4 (0.32) | 0 | 9 (0.02) |
Jaundice | 1 (0.08) | 2 (0.18) | 6 (0.01) |
LFT abnormal | 21 (1.70) | 26 (2.36) | 1578 (3.50) |
Chronic liver disease | 5 (0.40) | 4 (0.36) | 75 (0.17) |
Cholelithiasis | 0 | 2 (0.18) | 0 |
Other liver pathology | 4 (0.32) | 4 (0.36) | 131 (0.29) |
Renal impairment/failure | 18 (1.46) | 33 (3.00) | 969 (2.15) |
Other renal condition | 25 (2.02) | 28 (2.54) | 107 (0.24) |
Malignant neoplasm | 17 (1.38) | 9 (0.82) | 1013 (2.25) |
Congestive heart failure | 4 (0.32) | 11 (1.00) | 240 (0.53) |
Diabetes | 57 (4.61) | 60 (5.45) | 1409 (3.12) |
Obesity (BMI > 30) | 51 (4.13) | 57 (5.18) | 4633 (10.27) |
Presenting characteristics, [n (%)] | |||
Trauma | 1213 (98.14) | 1077 (97.82) | NC |
Musculoskeletal condition | 468 (37.86) | 404 (36.69) | NC |
Crush injury | 55 (4.45) | 57 (5.18) | NC |
Head injury | 34 (2.75) | 58 (5.27) | NC |
Altered level of consciousness | 17 (1.38) | 24 (2.18) | NC |
Heavy bleeding | 14 (1.13) | 13 (1.18) | NC |
Loss of consciousness | 11 (0.89) | 9 (0.82) | NC |
Acute abdominal condition | 1 (0.08) | 2 (0.18) | NC |
Clinically relevant hypotension | 1 (0.08) | 1 (0.09) | NC |
Clinically evident respiratory depression | 1 (0.08) | 1 (0.09) | NC |
Cardiac disorder | 0 | 2 (0.18) | NC |
Renal injury | 0 | 1 (0.09) | NC |
Medications received within 12 weeks before index date, [n (%)] | |||
Fluorinated anaesthetics | 18 (1.46) | 5 (0.45) | NC |
Known hepatotoxic drugs | 133 (10.76) | 134 (12.17) | 17260 (38.26) |
Other additional analgesics used at the index date, [n (%)] | |||
Paracetamol | 339 (68.5) | 333 (74.2) | NC |
codeine and paracetamol | 21 (4.2) | 32 (7.1) | NC |
Lidocaine | 35 (7.1) | 16 (3.6) | NC |
Dihydrocodeine and paracetamol | 19 (3.8) | 12 (2.7) | NC |
Propofol | 20 (4.0) | 7 (1.6) | NC |
Codeine | 9 (1.8) | 15 (3.3) | NC |
Midazolam | 14 (2.8) | 10 (2.2) | NC |
Fentanyl | 11 (2.2) | 6 (1.3) | NC |
Diazepam | 6 (1.2) | 8 (1.8) | NC |
Levobupivacaine | 5 (1.0) | 3 (0.7) | NC |
Bupivacaine | 5 (1.0) | 1 (0.2) | NC |
Ibuprofen | 2 (0.4) | 3 (0.7) | NC |
Local anaesthetic | 2 (0.4) | 0 (0.0) | NC |
Morphine | 2 (0.4) | 0 (0.0) | NC |
Amoxicillin and clavulanic | 1 (0.2) | 0 (0.0) | NC |
Dihydrocodeine | 0 (0.0) | 1 (0.2) | NC |
Gabapentin | 1 (0.2) | 0 (0.0) | NC |
Pethidine | 1 (0.2) | 0 (0.0) | NC |
Pregabalin | 0 (0.0) | 1 (0.2) | NC |
Prilocaine | 0 (0.0) | 1 (0.2) | NC |