Effects of Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery (FLUIDVOMIT)
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
%0.9 NaCl 10ml/kg
%0.9 NaCl 20ml/kg
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring fluid infusion, vomiting, otorhinolaringology
Eligibility Criteria
Inclusion Criteria:
- 2-14 years
- ASA I-II
Exclusion Criteria:
- Gastroesafageal reflu
- Premedication antiemetic
Sites / Locations
- Adnan Menderes University Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group I (%0.9 NaCl 10ml/kg)
Group II (%0.9 NaCl 20ml/kg)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pain
Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).
Full Information
NCT ID
NCT03485443
First Posted
March 26, 2018
Last Updated
December 4, 2018
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT03485443
Brief Title
Effects of Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
Acronym
FLUIDVOMIT
Official Title
Effects of Intraoperative Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
fluid infusion, vomiting, otorhinolaringology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
The postoperative assessment following the anesthesiologist, nurse and parents were blind during the entire study group
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (%0.9 NaCl 10ml/kg)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group II (%0.9 NaCl 20ml/kg)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
%0.9 NaCl 10ml/kg
Intervention Description
Fluid administration
Intervention Type
Drug
Intervention Name(s)
%0.9 NaCl 20ml/kg
Intervention Description
Fluid administration
Primary Outcome Measure Information:
Title
vomiting
Description
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
Time Frame
postoperative first 30 min
Secondary Outcome Measure Information:
Title
Pain
Description
Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).
Time Frame
postoperative first 30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
2-14 years
ASA I-II
Exclusion Criteria:
Gastroesafageal reflu
Premedication antiemetic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sinan yılmaz
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes University Training and Research Hospital
City
Aydın
ZIP/Postal Code
09100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
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