Zahedi 2009.
Methods | Double‐blind randomized controlled trial | |
Participants | Age (years, mean ± SD): Group NS = 28.9 ± 7.4, Group L = 29.7 ± 6.8, Group K50 = 29.4 ± 7.8, Group K75 = 29.7 ± 8.8, Group K100 = 30.7 ± 6.6 Gender (M:F): Group NS = 55:45, Group L = 51:49, Group K50 = 48:52, Group K75 = 56:44, Group K100 = 49:51 Inclusion criteria: age 18 years to 40 years old, ASA I‐II, elective strabismus surgery Exclusion criteria: patients taking sedatives or analgesics in the past 24 hours before surgery and those with history of allergic reactions to anaesthetic drugs, neurologic or cardiovascular disease and pregnant patients Recruitment: 500 adult patients randomly assigned (100 in each group) Setting: Iran |
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Interventions |
Pretreatment alone Patients were randomly allocated into five groups: patients received normal saline (Group NS) lidocaine 1 mg/kg (Group L) different doses of ketamine, 50 μg/kg, 75 μg/kg or 100 μg/kg (Group K50, K75, K100 respectively), pretreated immediately before the injection of 2.5 mg/kg propofol Each patient’s pain scores were measured at five‐second intervals by a blinded anaesthesiologist |
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Outcomes | Pain intensity assessed on 4‐point scale 0 = none 1 = mild pain 2 = moderate pain 3 = severe pain Outcomes reported and used
Outcomes sought but not reported
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Notes | Period of the study: dates not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | N/A |
Allocation concealment (selection bias) | Unclear risk | N/A |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Study drugs were diluted with NS 0.9% up to 5cc and were prepared by an investigator not involved in drug injection or assessment of patients' responses." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "A blinded anaesthesiologist before the administration of propofol asked the patient to rate any sensation of pain." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | Unclear risk | N/A |
Other bias | Low risk | The study appears to be free of other sources of bias |
Abbreviations used in tables: ASA = American Society of Anesthesiologists physical status classification ENT = Ear Nose Throat hr = hour kg = kilograms LCT = Long‐chain triglyceride MCT = Medium‐chain triglyceride μg = micrograms mg = milligrams ml = millilitres min = minutes n o = number N/A = not available NSAIDs = Non‐steroidal antiinflammatory drugs sec = seconds yr = years