TABLE 1.
| RCT | 1 (Aug 91-Dec 92) | 2 (?Dates) | |||||
|---|---|---|---|---|---|---|---|
| Controls (‘Low-dose’) | Cases (‘High-dose’) | Controls | Cases | ||||
| Number | 36 | 36 | 55 | 55 | |||
| Dose | Bolus: 22/mg/kg dose | No bolus loading dose | Placebo saline only | No bolus loading dose | |||
| (estimated /kg - see legend) | No infusion | Day 1: 5.6mg/kg/hr | Days 1-3: 3.7mg/kg/hr | ||||
| Day 2: 2.8mg/kg/hr | |||||||
| Day 3: 1.8mg/kg/hr | |||||||
| Day 4: 0.9mg/kg/hr | |||||||
| Pesticides | dimethyl OPs | 56% | 61% | Not stated | Not stated | ||
| diethyl Ops | 25% | 22% | |||||
| unknown | 19% | 17% | |||||
| Time from ingestion to start of Rx | <6hrs | 8 | 3 | <5hrs | 14 | 8 | |
| 6-12hrs | 6 | 14 | 6-10hrs | 13 | 15 | ||
| 12-24hrs | 15 | 10 | 11-15hrs | 12 | 9 | ||
| 24-36hrs | 5 | 5 | 16-20hrs | 4 | 9 | ||
| 36-48hrs | 2 | 4 | >21hrs | 10 | 9 | ||
| Pseudocholinesterase levels | 338.9 (260.5) | 441.3 (450.3) | 743.7 (1254) | 283.2 (243) | |||
| Deaths | 5 (14%) | 8 (22%) | 3 (5%) | 16 (29%) | |||
| Ventilated | 17 (47%) | 24 (67%) | 22 (40%) | 37 (67%) | |||
| Intermediate syndrome | 13 (36%) | 20 (56%) | 19 (35%) | 36 (65%) | |||
The two published RCTs of pralidoxime from the Christian Medical College, Vellore. Patients recruited to the trial were on the medical ITU with a history and signs/symptoms suggestive of organophosphate poisoning plus a pseudocholinesterase level <50% of normal; the number of patients excluded was not stated. Randomisation was in blocks of four; methods of concealment to reduce bias were not stated. Patient weight was not stated; to estimate quantities of pralidoxime given to patients as mg/kg, an estimated mean weight of 45kg was used [patients in a poisoning RCT in Sri Lanka had a mean weight of 48.2kg (SD 8.9)43].