Amir 2007.
Methods | Parallel‐group randomized trial, conducted in India. Study dates not reported. | |
Participants | 40 children and adults undergoing middle ear surgery. Exclusion: People with cardiovascular disease, central nervous system problems, previous history of PONV and/or motion sickness, and smokers. No details about withdrawals or loss to follow‐up. | |
Interventions | Group 1: electro‐acupuncture at frequency of 4 Hz and current intensity increased to a degree just less than what caused discomfort, given 20 min before induction for duration of surgery (n = 20). Group 2: sham electro‐acupuncture. No details given except that participants experienced needle pricks (n = 20). |
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Outcomes | Nausea (0 ‐ 24 h), vomiting (0 ‐ 24 h), risk of rescue antiemetic drug (0 ‐ 24 h), risk of adverse effects. | |
Notes | Rescue antiemetic was ondansetron 4 mg IV after first episode of PONV and repeated when necessary at 6‐hourly intervals. No side effects in sham electro‐acupuncture group. Erythema occurred in 3 participants in the electro‐acupuncture group. No details about funding source or any declarations of interest among authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Informed consent was taken from the selected patients and they were divided into two groups of twenty each using a computer‐generated table of random numbers". |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding of patients (performance bias) All outcomes | Unclear risk | Insufficient information. |
Blinding of healthcare providers (performance bias) All outcomes | Unclear risk | Insufficient information. |
Blinding of outcome assessor (detection bias) All outcomes | Low risk | "A blinded observed collected postoperative data of PONV". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data reported for the 20 participants randomized to each group. |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported. |
Other bias | Low risk | Baseline characteristics were comparable. "Differences in mean age, weight, sex and duration of surgery were statistically insignificant". |