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. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

Yilmaz 2014.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Turkey
 Multisite: no
 International: no
 Treatment duration: intraoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): tonsillectomy or adenotonsillectomy, or both
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 160 participants enrolled

  2. ASA I to II children aged 2 to 15 years undergoing elective tonsillectomy or adenotonsillectomy, or both


Exclusion criteria included:
  1. history of diabetes;

  2. mental retardation;

  3. obesity (body mass index greater than 95th percentile for age and sex);

  4. intake of antiemetic or psychoactive medication within 24 hours before surgery;

  5. known gastroesophageal reflux.


Randomized to:
  1. group 1 (n = 80, 50%);

  2. group 2 (n = 80, 50%);

  3. 6 patients were excluded from the study, 3 from each group, for failing to pass the inclusion and exclusion criteria.


Main characteristics of participants:
  1. age: group 1: all < 18 years; group 2: all < 18 years;

  2. number of females/males: 80/80.

Interventions
  1. Group 1 (control): intraoperative infusion of 10 mL/kg/hour normal saline

  2. Group 2 (intervention): intraoperative bolus of 20 mL/kg/hour normal saline


Co‐interventions: none stated
Outcomes
  1. Episodes of vomiting within the first 24 hours postoperatively were recorded and reported

Notes Trial registration: NCT02177201Funder: sponsored by Adnan Menderes University
 A priori sample size estimation: not stated
 Conducted: August 2013 to August 2014
 Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomly allocated, but no information on the randomization process was provided.
Allocation concealment (selection bias) Unclear risk Participants were randomly allocated, but no information on the allocation process was provided.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants, care providers, and investigators were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The outcome assessor was blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 6 participants, 3 from each arm, were excluded after beginning the study due to "meeting exclusion criteria".
Selective reporting (reporting bias) Low risk All outcomes were reported. Data were presented as an intention‐to‐treat analysis.
Other bias Low risk There were no other sources of bias.