Effects of Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery

NCT03485443 | Completed

• 1 other identifier: FLUID-VOMITING
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Otorhinolaryngological surgery is one of the commonly applied procedures surgical treatments of children in the world. Postoperative vomiting (POV) is an important part of the management of pediatric anesthesia in this surgery that is also related with these surgical procedures. Postoperative vomiting is one of the most common complication of this surgery and may cause patients to receiving anesthesia again and stay longer in the hospital.The use of effective fluid therapy might be a safe way to reduce POV. There are many studies of fluid therapy adult patients on the other hands the number of children studies are limited. The aim of this study was to evaluate the POV effect of intraoperative hydration with 0.9 NaCl solution in children undergoing otorhinolaryngological surgery.

Conditions

Postoperative Nausea and Vomiting

Keywords

fluid infusion; vomiting; otorhinolaringology

Outcome Measures

Primary Outcomes (1)

• vomiting

  Both nausea and vomiting were assessed on a four point scale: 0=no nausea/vomit, 1=mild nausea/vomit, patient not requesting metoclopramide, 2=nausea/vomit, patient requesting metoclopramide and 3=nausea/vomit resistant to treatment

  postoperative first 30 min

Secondary Outcomes (1)

• Pain

  postoperative first 30 min

Study Arms (2)

Group I (%0.9 NaCl 10ml/kg)

ACTIVE COMPARATOR

The group (Group 1) received 10 ml kg-1 throughout the entire surgical procedure. Four point scale using scored vomiting. m CHEOPS Scale using scored between 0-10.

Drug: %0.9 NaCl 10ml/kg

Group II (%0.9 NaCl 20ml/kg)

ACTIVE COMPARATOR

The group (Group 2) received 30 ml kg-1 throughout the entire surgical procedure. Four point scale using scored vomiting. m CHEOPS Scale using scored between 0-10.

Drug: %0.9 NaCl 20ml/kg

Interventions

%0.9 NaCl 10ml/kg DRUG

Fluid administration

Group I (%0.9 NaCl 10ml/kg)

%0.9 NaCl 20ml/kg DRUG

Fluid administration

Group II (%0.9 NaCl 20ml/kg)

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years
• ASA I-II

You may not qualify if:

• Gastroesafageal reflu
• Premedication antiemetic

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Adnan Menderes University Training and Research Hospital

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• sinan yılmaz

  Aydin Adnan Menderes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The postoperative assessment following the anesthesiologist, nurse and parents were blind during the entire study group
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adnan Menderes University

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: January 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

TU (1)