Demirhan 2013.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo (group P)
Dexamethasone (group PD)
Included criteria: ASA I and II, 18 to 75 years of age, waiting for elective rhinoplasty Excluded criteria: insufficient cooperation (e.g. psychiatric disorder, dementia); regular use of drugs (benzodiazepines, corticosteroids, tricyclic antidepressants, NSAIDs, or other analgesic drugs); preoperative current use of pregabalin or gabapentin; history of allergy to any of the study medications; pregnancy; obesity (body mass index > 35 kg/m²); significant cardiac, pulmonary, hepatic, or renal disease Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes |
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Interventions |
Intervention characteristics Placebo (group P)
Dexamethasone (group PD)
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 2 hours)
Nausea (0 to 24 hours)
Headache (0 to 24 hours)
Visual disturbances (e.g. blurred vision) (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Turkey Setting: inpatient, single‐centre Author's name: Abdullah Demirhan Institution: Department of Anesthesiology and Reanimation, Abant Izzet Baysal University Medical School, Golkoy, Bolu, Turkey Email: dr_demirhan1@hotmail.com Address: Department of Anesthesiology and Reanimation, Abant Izzet Baysal University Medical School, Golkoy, 14280 Bolu, Turkey Duration of study: NA Language: English Study's primary outcome: NA Trial registry number: NA |
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Notes | Two out of 3 groups relevant (co‐administration of pregabalin in both groups) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computer‐generated list of random numbers" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "by the same researcher who was not involved in the intraoperative or postoperative treatment and data collection" Quote: "...P and PD, and a similar‐looking placebo capsule was given to the controls (Group C) by the same researcher who was not involved in the intraoperative or postoperative treatment and data collection. The exact same packaging was used for the placebo capsules as the active capsules. In the operating room, intravenous..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the NRS values were recorded at 30 min and 1 h in the PACU and at 2, 4, 8, 12, and 24 h in the inpatient unit by the same researcher who was totally unaware of the patient groups" |
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: "Group P and Group PD exhibited statistically significant lower tramadol consumption compared to Group C within the 0–24‐h postoperative period (p \ 0.01 for all). There was a statistically significant difference between Group P and Group PD with respect to tramadol consumption (p = 0.016) only in the first 1‐h period. Table 2 and Fig. 1 give the mean tramadol consumption (mg) of the groups within the first 24‐h period" Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes |