Methods |
RCT, Double blind, single oral dose, parallel groups, general anaesthetic. Assessed by same nurse observer at 0, 1/2, 1 hr then hourly for 4 hrs. Medication given when pain of moderate to severe intensity. |
Participants |
Minor orthopaedic surgery
n = 120
Age: Adult |
Interventions |
Dextropropoxyphene HCl 65 mg + paracetamol 650 mg, n = 30
Placebo, n = 30 |
Outcomes |
PI (4 point scale) standard
PR (5 point scale) standard
Dextropropoxyphene + paracetamol was significantly better than placebo (P < 0.05) for TOTPAR
4 hr TOTPAR: Dextropropoxyphene + paracetamol: 7.37 Placebo: 4.70 |
Notes |
If remedicated before 4 hrs, last PI and PR score prior to remedication were used for all further time points.
120 participants data were analysed. No withdrawals were reported.
No serious adverse events were reported & no patients withdrew as a result.
Dextropropoxyphene + paracetamol: 16/30 patients reported 16 adverse events.
Placebo: 13/30 patients reported 13 adverse events.
QS = 3 |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Low risk |
A ‐ Adequate |