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

Heshmati 2004.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Iran
 Multisite: no
 International: no
 Treatment duration: intraoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): tonsillectomy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 90 participants enrolled

  2. ASA I children aged 6 to 12 years old with normal BMI scheduled for tonsillectomy under general anaesthesia


Exclusion criteria included:
  1. a history of motion sickness;

  2. PONV;

  3. recent common cold.


Randomized to:
  1. well‐hydrated group (n = 45, 50%);

  2. control group (n = 45 50%);

  3. no withdrawals were reported.


Main characteristics of participants:
  1. age (mean, standard deviation): well‐hydrated group 8 years, 3; control group 9 years, 3;

  2. number of females/males: 45/45.

Interventions
  1. Well‐hydrated group (intervention): intraoperative infusion of 4 mL/kg/hour Ringer's lactate in addition to standard fluid management

  2. Conservative fluid group (control): standard fluid management alone


Co‐interventions: none stated
Outcomes
  1. Nausea and vomiting were assessed as dichotomous outcomes.

  2. All episodes in the 24 hours following the operation were recorded. They were reported for the overall 24‐hours postoperative time period.

Notes Trial registration: not stated
 Funder: not stated
 A priori sample size estimation: not stated
 Conducted: dates not stated
 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 Unclear risk Blinding of care staff, including the intraoperative anaesthesiologist, was not described.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Nurses responsible for outcome assessment were blinded to allocation group.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals were noted.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.