Ashok 2017.
Methods |
Design: double‐blind, prospective randomized controlled trial Country: India Multisite: no International: no Treatment timing: intraoperative period Follow‐up: 24 hours postoperatively Operative procedure(s): lower abdominal and penile surgeries of less than 60 minutes duration Randomization unit: participants Analysis unit: individual |
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Participants |
Screened participants were excluded if:
Randomized to:
Main characteristics of participants:
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Interventions |
Co‐interventions: none stated |
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Outcomes |
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Notes | Trial registration: Clinical Trial Registry of India REF/2015/06/009178 Funder: Department of Anesthesiology and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India. A priori sample size estimation: stated on page 3 Conducted: dates not stated Declared conflicts of interest: authors report no conflict of interest | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization |
Allocation concealment (selection bias) | Unclear risk | Computer‐generated randomization |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The participants, parents or guardians, surgeons, PACU nurses, and the investigator performing the postoperative assessment were blinded to the group allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The participants, parents or guardians, surgeons, PACU nurses, and the investigator performing the postoperative assessment were blinded to the group allocation. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 participants lost to follow‐up (2 from the intervention arm, 3 from the control) are accounted for with reasons for exclusion provided. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Low risk | There were no other sources of bias. |