Cotton 2007.
| Methods | Prospective randomized study of IPA inhalation as compared to IV ondansetron for PONV. Replication of study: Winston 2003. Setting: PACU/same day surgery unit, USA |
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| Participants | 21 women aged 18‐65 who were scheduled for laparoscopic same‐day surgery (ASA physical status I, II or III), n = 10 treatment, n = 11 control Exclusions: patients who had recent upper respiratory tract infections, inability or impaired ability to breathe through the nose, or history of hypersensitivity to IPA, 5‐HT3 receptor antagonists, promethazine or any other anaesthesia protocol medication, had used an antiemetic within 24 hours of surgery, were pregnant or breastfeeding, had history of inner ear pathology, motion sickness or migraine headaches or were taking disulfiram, cefoperazone, or metronidazole |
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| Interventions | Comparison of inhaled IPA to intravenous ondansetron for treatment of PONV Ondansetron (control) group: nausea treated with ondansetron 4 mg IV every 15 min to a maximum 8 mg dose. Time, dose and VNRS score recorded IPA (experimental) group: nausea treated by holding a folded alcohol pad approximately 1/2 inch (approximately 1.3 cm) from the participant's nares and instructing them to take 3 deep breaths in and out through the nose. Treatments given every 5 min up to a total of 3 administrations Breakthrough PONV was treated with promethazine suppositories for both groups. Participants were also given supplies of IPA and promethazine to use as needed at home after discharge and asked to record any occurrences of PONV with a data collection tool provided by the researchers. |
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| Outcomes | Time to reduction in nausea score as measured by VRNS (range 0‐10 where 0 = no nausea and 10 = worst imaginable nausea). Collected for baseline at pre op, 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. Participants also reported data on PONV for the 24 h post‐discharge as well rating their anaesthesia experience overall. |
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| Notes | Author, Joseph Pellegrini contacted for further data. Some was provided however due to data corruption problems not all requested data were available. Support was received from the US Navy Clinical, Investigation Department. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "patient was randomly assigned to the control group or the experimental group by using a computer‐generated random numbers program." Comment: done |
| 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" (emailed author response) Comment: done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information given regarding blinding. Does not appear to have been done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information given regarding blinding. Does not appear to have been done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 28 participants "disenrolled due to protocol violations": 12 from control group who were given IPA postoperatively; 6 from experimental group given other antiemetics in PACU before IPA; and 10 who lost their IPA or promethazine following discharge to home. Comment: probably done |
| 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 |