N/A N=160 Randomized Quadruple-blind Supportive Care

Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

Postoperative Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT02177201 ↗

Enrolled (actual)

160

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Postoperative Vomiting — 11; 9; 66; 68 participants — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Group 1 (Other); Group 2 (Other)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Aydin Adnan Menderes University
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Postoperative Vomiting	11; 9; 66; 68	0.05

Summary

Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.

Eligibility Criteria

Inclusion Criteria:ASA physical status I or II

Age 2-15 yr
Scheduled for elective tonsillectomy and/or adenotonsillectomy

Exclusion Criteria

History of diabetes
History of mental retardation
Obesity (BMI = > 95th percentile for age and sex)
Intake of antiemetic or psychoactive medication within 24 hours before surgery
Known gastroesophageal reflux

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Data sourced from ClinicalTrials.gov (NCT02177201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.