Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Rodrigo 1994.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 38

  • Age (mean ± SD, median (IQR), median (range)): 24 ± 5.1

  • Weight (mean ± SD, median (IQR), median (range)): 53 ± 8.9

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 60.5

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

  • Type of general anaesthesia: balanced (fentanyl, N₂O, isoflurane)

  • Duration of anaesthesia (in min; as mean or median): 48

  • Use of perioperative opioids (if yes, which?): fentanyl, morphine

  • Type of surgery: removal of impacted third molar teeth


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 39

  • Age (mean ± SD, median (IQR), median (range)): 26 ± 7.6

  • Weight (mean ± SD, median (IQR), median (range)): 55 ± 9.1

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 56.4

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

  • Type of general anaesthesia: balanced (fentanyl, N₂O, isoflurane)

  • Duration of anaesthesia (in min; as mean or median): 47

  • Use of perioperative opioids (if yes, which?): fentanyl, morphine

  • Type of surgery: removal of impacted third molar teeth


Included criteria: 18 to 48 years of age, ASA I or II, scheduled to undergo minor oral surgery (removal of impacted third molar teeth) that could not be carried out under local anaesthesia
Excluded criteria: males weighing more than 120 kg, females weighing more than 100 kg, pregnant, breastfeeding, allergic to ondansetron
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 6.25 mg prochlorperazine IM


Placebo
  • Dose: 2 mL saline

  • Time point of administration: immediately before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 6.25 mg prochlorperazine IM

Outcomes Vomiting (0 to 24 hours)
  • Outcome type: dichotomous outcome


PONV (0 to 24 hours)
  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)
  • Outcome type: dichotomous outcome


Constipation (0 to 24 hours)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: Glaxo (Hong Kong Ltd) supplied ondansetron
Country: Hong Kong
Setting: inpatient, single‐centre
Author's name: M.R.C. Rodrigo
Institution: Department of Maxillofacial Surgery, Dental Faculty, University of Hong Kong
Email: NA
Address: Block 1, Flat A8, 23 Sha Wan Drive, Pokfulam, Hong Kong
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: quote: "random allocation chart"
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "double‐blind study"
Judgement comment: quote: "the test drug was drawn up by the nursing officer of the operating theatre and was given by the anaesthetist, thus making it blind to patients, the anaesthetist and the surgeons"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: quote: "eighty patients were included in the study. Of these results, three patients were eliminated as instead of paracetamol two had been given oral difluisal and one Panadeine..."
Reasons for exclusion described and unrelated to the outcomes of interest
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear