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

• ClinicalTrials.gov Identifier: NCT03485443
• Recruitment Status: Completed
• First Posted: April 2, 2018
• Last Update Posted: December 5, 2018
• Sponsor: Aydin Adnan Menderes University
• Information provided by (Responsible Party): SİNAN YILMAZ, Aydin Adnan Menderes University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Nausea and Vomiting	Drug: %0.9 NaCl 10ml/kg; Drug: %0.9 NaCl 20ml/kg	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Masking Description: The postoperative assessment following the anesthesiologist, nurse and parents were blind during the entire study group
• Primary Purpose: Prevention
• Official Title: Effects of Intraoperative Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: June 1, 2018
• Actual Study Completion Date: June 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. vomiting [ Time Frame: postoperative first 30 min ]
   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

Secondary Outcome Measures :

1. Pain [ Time Frame: postoperative first 30 min ]
   Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 2-14 years
• ASA I-II

Exclusion Criteria:

• Gastroesafageal reflu
• Premedication antiemetic

Contacts and Locations

Locations

Turkey

Adnan Menderes University Training and Research Hospital

Aydın, Turkey, 09100

Sponsors and Collaborators

Aydin Adnan Menderes University

Investigators

• Principal Investigator: sinan yılmaz; Aydin Adnan Menderes University

More Information

• Responsible Party: SİNAN YILMAZ, Adnan Menderes University, Aydin Adnan Menderes University
• ClinicalTrials.gov Identifier: NCT03485443
• Other Study ID Numbers: FLUID-VOMITING
• First Posted: April 2, 2018
• Last Update Posted: December 5, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SİNAN YILMAZ, Aydin Adnan Menderes University:

fluid infusion; vomiting; otorhinolaringology

Additional relevant MeSH terms:

Vomiting; Postoperative Nausea and Vomiting; Nausea; Signs and Symptoms, Digestive; Postoperative Complications; Pathologic Processes