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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: %0.9 NaCl 10ml/kg; Drug: %0.9 NaCl 20ml/kg

Detailed Description

After institutional ethics committee approval and written informed parental consent, ASA physical status I or II, aged 2-14 year, who were undergoing elective day case otorhinolaryngological surgery under general anaesthesia, were screened for eligibility for enrollment in this prospective, randomized, double blind, placebo controlled study.

In the operating room, after routine monitoring, general anaesthesia was induced with %8 sevoflurane in 100% oxygen by a face mask with spontaneous ventilation.

Patients were randomly assigned to one of the two groups. Randomization was carried out using a computer-generated random numbers.

The control group (Group I) received ≤10 ml kg-1 h-1 and the high volüme group ( Group II) received >30 ml kg-1h-1 of intravenous %0.9 NaCl solution.Before tracheal intubation, all subjects received propofol 2:5mg kg-1, fentanyl 1µg kg-1 and rocuronium 0.6 mg kg-1.

After tracheal intubation, anaesthesia was maintained with 40% mixture of oxygen/nitrous oxide and 2% sevoflurane. The solution appears to be covered via an infusion pump was used. During anaesthesia, all patients received intravenous paracetamol 10 mg kg-1 for postoperative pain .

Following extubation, until the transfer of the patient from the time of the PACU nausea, vomiting or both were recorded..

Retching efforts in the PACU were recorded as nausea evaluated. 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 At the first episode of severely nause and vomiting, or both, a rescue antiemetic consisting of intravenous ondansetron was administered.

Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).

Knowledge collection for posoperative pain to PACU arrival and departure was performed by a postanesthesia care unit (PACU) nurses who blinded to the procedure the amount of fluid therapy.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Aydın, Turkey, 09100
    • Adnan Menderes University Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 2-14 years
• ASA I-II

Exclusion Criteria:

• Gastroesafageal reflu
• Premedication antiemetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group I (%0.9 NaCl 10ml/kg); 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; Fluid administration
ACTIVE_COMPARATOR: Group II (%0.9 NaCl 20ml/kg); 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; Fluid administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).	postoperative first 30 min

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): June 1, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (ACTUAL): April 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: vomiting; fluid infusion; otorhinolaringology
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: FLUID-VOMITING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No