White 2002.
Methods | Parallel‐group randomized trial, conducted in United States. Study dates not reported. | |
Participants | 120 adults undergoing elective plastic surgery. Excluded: antiemetic medication within 24 h before surgery, pregnancy, using permanent cardiac pacemaker, previous experience with acustimulation treatment, experiencing vomiting or retching within 24 h before surgery. No participants withdrew before discharge from hospital, 5 participants withdrew from study at 72 hours follow‐up. | |
Interventions | Group 1: ondansetron 4 mg and inactive acustimulation device (ReliefBand) at P6 acupoint on arrival in the recovery room. Device worn for 72 hours after surgery (n = 40). Group 2: saline 2 mL and active acustimulation device (ReliefBand) at P6 acupoint on arrival in the recovery room. Device worn for 72 hours after surgery (n = 40). Group 3: ondansetron 4 mg and active acu‐stimulation device (ReliefBand) at P6 acupoint on arrival in the recovery room. Device worn for 72 hours after surgery (n = 40). |
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Outcomes | Nausea (0 ‐ hospital discharge), vomiting (0 ‐ hospital discharge), risk of rescue antiemetic drug, side effects. | |
Notes | Rescue antiemetic was metoclopramide 10 mg IV if persistent nausea or vomiting, or retching lasting more than 10 min. No swelling at wrist or erythema reported. No outcome measures (0 ‐ 72 h) given in the paper. Funding source from department. First author received past funding from both Woodside Biomedical systems and GlaxoSmith‐Kline. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Patients were randomly assigned to one of three treatment groups using a computer‐generated random number table...". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding of patients (performance bias) All outcomes | Low risk | All participants were told that the ReliefBand acu‐stimulation device produces a sensation which they may or may not feel to minimize bias. Participants recorded outcome measures in a participant diary. |
Blinding of healthcare providers (performance bias) All outcomes | Unclear risk | Insufficient information. |
Blinding of outcome assessor (detection bias) All outcomes | Low risk | All participants were told that the ReliefBand acustimulation device produces a sensation which they may or may not feel to minimize bias. Participants recorded outcome measures in a participant diary. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant lost to follow‐up in ondansetron group, 1 lost to follow‐up in acu‐stimulation group, and 3 lost to follow‐up in combination group. Author used intention to treat analysis. |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported. |
Other bias | Low risk | Baseline characteristics were comparable. "The three treatment groups were comparable with respect to demographic characteristics, pre‐existing risk factors for development of PONV, and preoperative nausea scores". |