- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575600
Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative vomiting is a common complication on pediatric surgery, especially otorhinolaryngological surgery. Is one of the main reasons of prolonged hospital stay, and also a cause of patient´s discomfort and an increase on hospitalization cost.
There are studies in adults with inconclusive results related to supplemental fluid therapy and decrease of postoperative nausea and vomiting. But, in recent years a study in children showed favorable results in strabismus surgery. The foundation of this study consist in that hypovolemia may possibly cause a decrease in perfusion causing intestinal hypoxia, which in turn increase the incidence of nausea and vomiting. The objective of this study is to observe the effect of supplemental fluid therapy on postoperative vomiting on otorhinolaryngological surgery.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Region Metropolitana
-
Santiago, Region Metropolitana, Chile
- Hospital Clinico Universidad Catolica
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA physical status I or II
- Age 1-12 yr
- Scheduled for elective tonsillectomy or adenotonsillectomy
Exclusion Criteria:
- History of diabetes
- History of mental retardation
- Obesity (BMI ≥95th percentile for age and sex)
- Intake of antiemetic or psychoactive medication within 24 hours before surgery
- Known gastroesophageal reflux
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 10 mL/kg/h lactated Ringer's solution
Group 1, 10 mL/kg/h lactated Ringer's solution
|
After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.
|
Experimental: 30 mL/kg/h lactated Ringer's solution
Group 2, 30 mL/kg/h lactated Ringer's solution
|
After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vomiting at 24 hours postoperative
Time Frame: First 24 hours postoperative
|
Presence of at least one episode of vomiting in the first 24 hours postoperative
|
First 24 hours postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Vomiting
-
Vestre VikenHF Kongsberg SykehusNorwegian Medical AssociationCompletedPostoperative Complications | Postoperative Pain | Postoperative Vomiting and Nausea | Mental Status Changes PostoperativeKazakhstan, Russian Federation
-
Instituto Materno Infantil Prof. Fernando FigueiraUniversidade Federal de PernambucoCompleted
-
Oregon Health and Science UniversityCompletedPostoperative Vomiting and NauseaUnited States
-
Northwell HealthTerminatedPostoperative Pain | Postoperative Nausea | Postoperative VomitingUnited States
-
Hôpital Privé de Parly II - Le ChesnayCompletedPostoperative Nausea | Postoperative Vomiting | Postoperative EmesisFrance
-
Yeungnam University College of MedicineCompletedPostoperative Nausea | Postoperative VomitingKorea, Republic of
-
Methodist Health SystemRecruitingNausea, Postoperative | Vomiting, PostoperativeUnited States
-
Siriraj HospitalBuddhachinaraj HospitalCompletedPostoperative Nausea and Vomiting | Postoperative Nausea | Postoperative VomitingThailand
-
Assistance Publique - Hôpitaux de ParisCompletedPostoperative VomitingFrance
-
Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
Clinical Trials on Intraoperative lactated Ringer's solution
-
Mahidol UniversityCompleted
-
McGill University Health Centre/Research Institute...UnknownIntestinal Disease | Feeding Disorder NeonatalCanada
-
Milton S. Hershey Medical CenterLehigh Valley Hospital; St. Luke's Hospital, Pennsylvania; The Reading Hospital...Completed
-
McGill University Health Centre/Research Institute...UnknownActual Impaired Fluid Volume
-
The First Affiliated Hospital with Nanjing Medical...RecruitingHepatic IschemiaChina
-
Dankook UniversityWonkwang University; University of UlsanCompletedPost-ERCP Acute PancreatitisKorea, Republic of
-
University of NottinghamUnknownPatients Undergoing Open Resection of Colorectal TumoursUnited Kingdom
-
Mahidol UniversityUnknownColonoscopy | Bowel Preparation
-
Yale UniversityRecruitingCoronary Artery Bypass Graft Surgery | Aortic Valve ReplacementUnited States
-
Zhongnan HospitalUnknownSeptic Shock | Intensive Care Unit | Fluid Resuscitation | Crystalloid SolutionChina