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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Shirdashtzadeh 2011.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Promethazine

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 25

  • Received treatment (n): 25

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 27 ± 5.3

  • Weight (mean ± SD, median (IQR), median (range)): 56 ± 6.1

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

  • ASA I/II/III/IV (n): 25/0/0/0

  • Gender (female in %): 0

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 44

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

  • Type of surgery: appendectomy


Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 25

  • Received treatment (n): 25

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 23.5 ± 5.8

  • Weight (mean ± SD, median (IQR), median (range)): 57 ± 5.2

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

  • ASA I/II/III/IV (n): 25/0/0/0

  • Gender (female in %): 0

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (halothane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 27

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

  • Type of surgery: appendectomy


Included criteria: ASA I, 15 to 40 years of age, listed for elective appendectomy
Excluded criteria: female, younger than 15 and older than 40 years of age, systematic disease (diabetes), took any drugs before surgery, haemodynamic disturbance within surgery
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, non‐smoker, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia): yes
Interventions Intervention characteristics
Promethazine

  • Dose: 1 mg/kg

  • Time point of administration: 5 minutes before surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Placebo

  • Dose: placebo

  • Time point of administration: 5 minutes before surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA
Outcomes Vomiting (0 to 6 hours)

  • Outcome type: dichotomous outcome


Vomiting (6 to 12 hours)

  • Outcome type: dichotomous outcome


PONV (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: NA
Country: Iran
Setting: inpatient, single‐centre
Author's name: Azadeh Eshraghi
Institution: Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran
Email: eshraghi_a82@yahoo.com
Address: Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes Two out of 3 groups relevant
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the patients were randomly allocated to receive one of the three regimens"
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "the intravenous medications were coded and given 5 minutes prior to surgery"
Judgement comment: insufficient information on blinding ("double‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "24 hours (every 6 hours) after anesthesia were gathered and recorded by a trained investigator with no knowledge of which treatment the patients had received..."
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias High risk Quote: "the characteristics of the patients in the three treated groups are shown in table 1"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, non‐smoker, history of PONV/motion sickness, perioperative opioids): no; (duration of anaesthesia): yes