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

Egeli 2004.

Methods Design: double‐blind, prospective randomized controlled trial
 Country: Turkey
 Multisite: no
 International: no
 Treatment duration: postoperative period
 Follow‐up: 1 week postoperatively
 Operative procedure(s): adenotonsillectomy
 Randomization unit: participants
 Analysis unit: individual
Participants
  1. 40 participants enrolled

  2. Children aged 4 to 18 years undergoing adenotonsillectomy under general anaesthesia with endotracheal intubation for chronic infection, obstructive hypertrophy, or both


Exclusion criteria included:
  1. the presence of systemic or neurologic diseases;

  2. bleeding disorders.


Randomized to:
  1. group A (n = 20, 50%);

  2. group B (n = 20, 50%).


Main characteristics of participants:
  1. age (mean, standard deviation): Group A 8.25 years, 2.75; Group B 8.20 years, 3.90;

  2. number of females/males: 11/29.

Interventions
  1. Group A (intervention): postoperative infusion of 60 to 120 mL/hour 5% dextrose in Ringer's lactate

  2. Group B (control): no postoperative hydration


Co‐interventions: none stated
Outcomes
  1. Nausea and vomiting assessed as dichotomous outcomes using a questionnaire completed by the participant's parent on postoperative day 0, 1, 2, 3, 4, 5, and 6.

  2. Also assessed on the questionnaire were halitosis, bleeding, otalgia, trismus, fever, and 'other'.

  3. Intensity and progression of pain were assessed using the McGrath's face scale at postoperative hours 1, 5, 13, 17, and 21, as well as on postoperative days 1, 2, 3, 4, 5, and 6.

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 No information on the randomization protocol was provided.
Allocation concealment (selection bias) Unclear risk No information on the randomization protocol was provided.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and their parents were aware of group allocation as the intervention was postoperative IV fluid administration.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk The (unblinded) parent completed the questionnaire and used the McGrath Face Scale to assess pain.
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.