Postoperative VomitingPhase 3NCT01575600
Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
A Phase 3 study testing Intraoperative lactated Ringer's solution in people with Postoperative Vomiting, run by Ignacio Cortínez F. at 1 site in Chile.
Trial summary
The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Postoperative Vomiting
- What is being tested?
- Intraoperative lactated Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- Jul 2010to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I or II
- Age 1-12 yr
- Scheduled for elective tonsillectomy or adenotonsillectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clinico Universidad Catolica
Santiago, Santiago Metropolitan
About this study
The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting.
Read the 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.
- Conditions
- Postoperative Vomiting
- Being tested
- Intraoperative lactated Ringer's solution
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative lactated Ringer's solutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 mL/kg/h lactated Ringer's solution | Active comparator | Group 1, 10 mL/kg/h lactated Ringer's solution Receives: Other: Intraoperative lactated Ringer's solution |
| 30 mL/kg/h lactated Ringer's solution | Experimental | Group 2, 30 mL/kg/h lactated Ringer's solution Receives: Other: Intraoperative lactated Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vomiting at 24 hours postoperative
Presence of at least one episode of vomiting in the first 24 hours postoperative
Measured: First 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJul 2010
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ignacio Cortínez F.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ignacio Cortínez F., Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575600
- Sponsor's protocol ID
- 10-095
- Status last verified
- May 2012
- First submitted
- 10 Apr 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery
- ClinicalTrials.gov ID
- NCT01575600
- Acronym / sponsor ID
- 10-095
- Conditions
- Postoperative Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ignacio Cortínez F.University, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 mL/kg/h lactated Ringer's solution | Active comparator | Other: Intraoperative lactated Ringer's solutionGroup 1, 10 mL/kg/h lactated Ringer's solution |
| 30 mL/kg/h lactated Ringer's solution | Experimental | Other: Intraoperative lactated Ringer's solutionGroup 2, 30 mL/kg/h lactated Ringer's solution |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I or II
- Age 1-12 yr
- Scheduled for elective tonsillectomy or adenotonsillectomy
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative lactated Ringer's solutionAfter 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. | Other | 10 mL/kg/h lactated Ringer's solution, 30 mL/kg/h lactated Ringer's solution |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
Related trials for Postoperative Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intraoperative lactated Ringer's solution in people with Postoperative Vomiting, run by Ignacio Cortínez F. at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vomiting at 24 hours postoperative (time frame: First 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2012.