Skip to main content
. 2019 Mar 29;2019(3):CD012212. doi: 10.1002/14651858.CD012212.pub2

Goodarzi 2006.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: USA
 Multisite: no
 International: no
 Treatment duration: preoperative period
 Follow‐up: 24 hours postoperatively
 Operative procedure(s): ambulatory strabismus surgery under general anaesthesia
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 100 participants enrolled

  2. ASA I to II children aged 1 to 12 years undergoing ambulatory strabismus surgery under general anaesthesia


Exclusion criteria included:
  1. cardiovascular problems;

  2. respiratory problems;

  3. hepatic or renal problems;

  4. prior history of nausea and vomiting.


Randomized to:
  1. 10 group (n = 50, 50%);

  2. 30 group (n = 50, 50%).


Main characteristics of participants:
  1. age (mean, standard deviation): 10 group 5.6 years, 1.2; 30 group 5.3 years, 0.9;

  2. number of females/males: 50/50.

Interventions
  1. 10 group (control): intraoperative infusion of 10 mL/kg/hour Ringer's lactate

  2. 30 group (intervention): intraoperative infusion of 30 mL/kg/hour Ringer's lactate


Co‐interventions: none stated
Outcomes
  1. Nausea was assessed using an ordinal scale (none, mild, moderate, or severe) and dry retching/vomiting were assessed and reported as a dichotomous outcome. These outcomes were assessed during 2 time points: in PACU by direct observation and at 24 hours postoperatively by telephone questionnaire completed by the participant's parent.

  2. A patient with moderate nausea, severe nausea, and dry retching/vomiting was scored as having PONV.

  3. Other outcomes included the presence of thirst, postoperative pain, and fever. These outcomes were reported for the entire 24‐hour postoperative 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) Low risk Randomization was carried out using a computer program.
Allocation concealment (selection bias) Unclear risk Randomization was carried out using a computer program.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk PACU nurses were blinded to the allocation group, but blinding of the anaesthesiologist caring for participants was not stated.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Data collection was completed by a single investigator blinded to the technique of fluid therapy.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No withdrawals were stated.
Selective reporting (reporting bias) Low risk All outcomes were reported.
Other bias Low risk There were no other sources of bias.