Winston 2003.
Methods | RCT of IPA for treatment of PONV. Participants were randomized to receive either IPA inhalations, or 4 mg ondansetron. Setting: same day surgery centre, USA |
|
Participants | 41 women aged 18‐65 years who were scheduled for diagnostic laparoscopy, operative laparoscopy or laparoscopic bilateral tubal occlusion (ASA physical status I, II or III) in a day surgery unit. Treatment n = 29, control n = 12 Exclusions: inability or impaired ability to breathe through the nose, or history of sensitivity to IPA or ondansetron, had used an antiemetic within 24 h of surgery, pregnant or breastfeeding, reported existing nausea, history of significant PONV resistant to antiemetics, using disulfiram or had a history of alcoholism |
|
Interventions | Comparison of inhaled 70% IPA to ondansetron for treatment of PONV. Ondansetron (control) group: at first request for treatment participants in this group received IV ondansetron 4 mg, repeated once in 15 min if required. 70% IPA (experimental) group: a standard alcohol prep pad was held under the participant's nose and she was instructed to take 3 consecutive deep breaths through the nose. Nausea score collected for baseline at preop, then immediately postop in PACU and at any time the participant complained of nausea. Additionally, participants who complained of nausea were assessed every 5 min following treatment for 30 min and then every 15 min until discharge from PACU. |
|
Outcomes |
|
|
Notes | This study was replicated by Cotton 2007 with the number and frequency of IPA inhalations increased. Study author J Pellegrini provided additional data via email. No funding sources reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "subjects were randomly assigned to receive inhaled 70% IPA (experimental group) or IV ondansetron (control group) for the treatment of PON" "despite the use of block randomisation" Comment: study author states via email that randomization was conducted using a computer‐generated random numbers table. |
Allocation concealment (selection bias) | Low risk | "Block randomisation was used for all of the studies using a computer generated randomisation program done by an independent party (myself) who was not involved in the data collection." Comment: probably done |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "...this did not allow us to blind the study intervention." Comment: it appears that no blinding of participants or personnel was done |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "...this did not allow us to blind the study intervention." Comment: it appears that outcome assessors were not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: it appears that data were reported for all participants, no evidence of exclusions or attrition |
Selective reporting (reporting bias) | Unclear risk | Comment: original study protocol unavailable. Despite stating collection of data on patient satisfaction with anaesthetic experience, no results for this were reported, however these data were made available by a study author via email |
Other bias | Low risk | Comment: no other sources of bias apparent |
AD: admitting department; ASA: American Society of Anesthesiologists; CB: controlled breathing; CCT: controlled clinical trial; C‐section: cesarean section; DOS: descriptive ordinal scale; ENT: ear, nose, throat; GBP: Great Britain Pound; IPA: isopropyl alcohol; ITT: Intention‐to‐treat; ISO: isopropyl alcohol; IV: intravenous; PACU: post‐anaesthesia care unit; PON: postoperative nausea; PONV: postoperative nausea and vomiting; PP: per protocol; RCT: randomized controlled trial; RNs: registered nurses; SD: standard deviation; SDSU: same‐day surgery unit; USD: United States Dollar; VAS: visual analogue scale; VNRS: verbal numeric rating scale