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

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

Sponsors

Lead sponsor: Aydin Adnan Menderes University

Source Aydin Adnan Menderes University
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.

Overall Status Completed
Start Date January 1, 2018
Completion Date June 1, 2018
Primary Completion Date June 1, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
vomiting postoperative first 30 min
Secondary Outcome
Measure Time Frame
Pain postoperative first 30 min
Enrollment 160
Condition
Intervention

Intervention type: Drug

Intervention name: %0.9 NaCl 10ml/kg

Description: Fluid administration

Arm group label: Group I (%0.9 NaCl 10ml/kg)

Intervention type: Drug

Intervention name: %0.9 NaCl 20ml/kg

Description: Fluid administration

Arm group label: Group II (%0.9 NaCl 20ml/kg)

Eligibility

Criteria:

Inclusion Criteria:

- 2-14 years

- ASA I-II

Exclusion Criteria:

- Gastroesafageal reflu

- Premedication antiemetic

Gender: All

Minimum age: 2 Years

Maximum age: 14 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
sinan yılmaz Principal Investigator Aydin Adnan Menderes University
Location
facility
Adnan Menderes University Training and Research Hospital
Location Countries

Turkey

Verification Date

December 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Aydin Adnan Menderes University

Investigator full name: SİNAN YILMAZ

Investigator title: Adnan Menderes University

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group I (%0.9 NaCl 10ml/kg)

Arm group type: Active Comparator

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 group label: Group II (%0.9 NaCl 20ml/kg)

Arm group type: Active Comparator

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.

Acronym FLUIDVOMIT
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Prevention

Masking: Single (Investigator)

Masking description: The postoperative assessment following the anesthesiologist, nurse and parents were blind during the entire study group

Source: ClinicalTrials.gov