Anderson 2004.
Methods | RCT of peppermint oil, IPA or normal saline aromatherapy to treat PONV Setting: PACU acute hospital, USA |
|
Participants | 33 patients aged 18 years + having surgery under general or regional anaesthesia, or deep IV sedation, who reported nausea in PACU. Treatment groups did not differ in the percentage having general anaesthesia, the type of surgery, age or gender distribution. Exclusions: patients who were unable to give informed consent; patients who did not require anaesthesia services |
|
Interventions | On the participant's spontaneous report of PON, they were instructed to take three slow deep breaths to inhale the vapours from a pre‐prepared gauze pad soaked with either peppermint oil (n = 10), IPA (n = 11), or normal saline placebo (n = 12) held directly under their nostrils. After 2 min the participant was asked to rate their nausea by VAS and given the choice to continue aromatherapy or have standard IV antiemetics. At 5 min post the initial treatment, the participant was again asked to rate their nausea and if they would like to continue aromatherapy or have standard IV antiemetics. | |
Outcomes |
|
|
Notes | Possible lack of accuracy with some participants self‐recording data in PACU if they had poor or blurred vision. Authors Lynn Anderson and Dr Jeffrey Gross emailed to request further information on group sizes, which was supplied by Dr Gross. Supported by the Department of Anesthesiology, University of Connecticut School of Medicine. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...group assignments were made in a randomised, double‐blind fashion" Comment: probably done. Nurses administering treatment were unaware of contents of each package of treatment materials. Patients who had consented to participate entered study when they spontaneously reported nausea. |
Allocation concealment (selection bias) | Low risk | "A random number generator determined the contents of each serially numbered bag." "...prepared by an individual not otherwise involved in the study..." Data "analysed by investigator unaware of treatment allocation". Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Staff administering treatment blinded by use of "lightly scented" surgical masks. Comment: probably done |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants were self‐reporting subjective assessment of nausea and were not blinded. Comment: due to the strong aroma of the peppermint oil, it would be impossible to blind the participant receiving this to their allocation once treatment commenced. Probably not done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: outcomes reported for all participants |
Selective reporting (reporting bias) | Low risk | Comment: results reported for all stated outcomes |
Other bias | Low risk | Comment: study appears to be free of other sources of bias |