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

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
Participants
  1. 150 participants enrolled

  2. ASA I to II male and female children aged 3 to 7 years undergoing lower abdominal and penile procedures of less than 60 minutes duration


Screened participants were excluded if:
  1. they personally had a history of PONV or motion sickness;

  2. a sibling or parent or both, had a history of PONV;

  3. they received antiemetic medication in the 24 hours preceding surgery;

  4. their BMI exceeded 30 kg/m2;

  5. they had a history of cardiovascular or renal disease;

  6. developmental delay or mental retardation, or both;

  7. their parents could not be reached by telephone;

  8. they had a contraindication to caudal block.


Randomized to:
  1. liberal fluid (n = 72, 49.7%);

  2. restricted fluid (n = 73 50.3%);

  3. 5 patients were lost to follow‐up after they were discharged from PACU and were not included in the analysis (liberal group = 3, restricted group = 2).


Main characteristics of participants:
  1. age (mean, standard deviation): liberal group 5.1 years, 1.6; restricted group 5.3 years, 1.5;

  2. number of females/males: 134/11.

Interventions
  1. Liberal fluid group (intervention): intraoperative infusion of 30 mL/kg/hour Ringer's lactate

  2. Restricted fluid group (control): intraoperative infusion of 10 mL/kg/hour Ringer's lactate


Co‐interventions: none stated
Outcomes
  1. The risk of nausea, retching, and emesis were continuously evaluated during PACU stay. These outcomes were assessed directly (inpatients) or by phone interview with parents (ambulatory participants) and reported for the entire 24‐hour postoperative period.

  2. Time to first antiemetic was documented and reported as risk of fluid intake within 6 hours. Overall prevalence of thirst was reported.

  3. Postoperative pain, measured using the Face, Legs, Activity, Cry, Consolability pain scale (0 to 10 score range) was assessed but not specifically reported. Risk and timing of rescue analgesic administration were documented and reported for the entire 24‐hour postoperative period.

  4. Parents were contacted and asked to report overall parent satisfaction (0 to 10 range) 24 hours postoperatively.

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.