Orlinsky 2002.
Methods | Prospective randomized controlled trial. | |
Participants | Patients between the ages of 18 and 80 years with anterior shoulder dislocation. | |
Interventions | The IAL group received an intra‐articular injection of 20 ml of 1% lignocaine into the affected shoulder. The IVAS group sequentially received 1 to 2 mg/kg of meperidine and 5 to 10 mg of diazepam intravenously over 1 to 2 minutes. | |
Outcomes | Successful reduction was confirmed radiographically. Outcome measures were: recovery time, change in pain score from baseline to after anaesthesia but before reduction, change in pain score from after anaesthesia but prior to reduction to time of discharge, overall change in pain score from baseline to time of discharge, patient perceived inadequate analgesia, pain interference with procedure, insufficient relaxation interfering with procedure and number of patients with adverse effects. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Published study does not provide information regarding sequence generation. Quote: “Once a patient met the inclusion criteria, the physician pulled a pre‐numbered sealed envelope containing the written informed consent form and the protocol to which the patient was randomized, either the IAL or IVMD analgesia protocol”. |
Allocation concealment (selection bias) | High risk | Published study does not provide any information regarding allocation concealment. Comment: the nature of the interventions is such that allocation concealment is not feasible. |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: “Non‐blinded”. Comment: the nature of the interventions is such that blinding is not feasible. |