Vomiting PostoperativePhase 3vomitingNCT01297010
Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children
A Phase 3 study testing Dexamethasone and ondasetron and Dexamethasone in people with Vomiting Postoperative, run by Instituto Materno Infantil Prof. Fernando Figueira.
Trial summary
The majority of pediatric surgery takes place in an outpatient basis. The occurrence of postoperative vomiting can lead to a delay in hospital discharge. However, the use of postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects and also raises the final costs of the surgical… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Vomiting Postoperative
- What is being tested?
- Dexamethasone and ondasetron and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jul 2011
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I or II
- Patients aged between 1 and 10 years old
- Patients undergoing general anesthesia for surgical repair of hernia, cryptorchidism and phimosis
Who cannot join
- Officials who refused to sign the consent form
- ASA ≥ III
- History of allergy to dexamethasone and/or ondansetron
- Patients taking opioids preoperatively
- Patients using antiemetic drugs preoperatively
- Patients with vomiting preoperatively
About this study
Official title: Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled
The majority of pediatric surgery takes place in an outpatient basis. The occurrence of postoperative vomiting can lead to a delay in hospital discharge. However, the use of postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects and also raises the final costs of the surgical procedure. The Objective our study is Compare the incidence of postoperative vomiting between children who received dexamethasone, dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient surgery. This is a randomized, double blind, placebo-controlled study to comparing the use of dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting prophylaxis in children submitted to general anesthesia. Data analysis will be used is Fisher's exact test for the categorical variables and the Anova test for numerical variables as they presented Gaussian variation. The study used a significance level of 5%.
Read the detailed description
The investigators know that a large number of pediatric surgeries are performed on an outpatient basis and the occurrence of nausea and vomiting after surgery can lead to delayed discharge and increased hospital costs. Based on this fact, the investigators find it relevant to determine the incidence of postoperative vomiting in pediatric surgery patients to assess the need for antiemetic prophylaxis in this study population being developed in the surgical ward of the Hospital das Clinicas - Federal University of Pernambuco (HC-UFPE ).
The study will be conducted from March 2011 to September 2011.Pacientes pediatric ASA I and II underwent surgery in the pediatric surgical ward of the HC-UFPE.
The sample size calculation was performed in the program StatCalc Epi-Info 6.04d, based on data from relevant literature and determined the presence of 44 patients in each of the three groups, totaling 132 patients in the study.
Patients will be recruited in the preparation room anesthetic in surgical clinics of the Hospital for three shifts of existing pediatric surgery. After evaluation of each patient and then filled the criteria of inclusion and exclusion, those responsible will be informed about the procedures being undertaken and the possible consequences of their participation in research.
Only after signing an informed consent by the person responsible will be held the allocation of patients into three groups, after opening the sealed envelope containing the selected group for that participant. These envelopes are previously prepared by a person outside the research.
Therefore, the researcher has no prior knowledge of the group selected for the participant at the time of the consent solicitation.
At the end of the study will fill a flowchart with the profile of the trial, including the total number of patients, the number of eligible patients, the number of those who were offered participation in the study, the number of denied and his reason the number of patients who agreed to participate. The latter will be known only after statistical analysis Randomization to each specific group will be held in accordance with a table of random numbers previously generated computer (Random Allocation Software 1.0, 2004).
Independent variable
- Use of dexamethasone and ondansetron, or dexamethasone or placebo only
Dependent Variables
- Incidence of postoperative vomiting;
- The need for antiemetic therapy in the recovery room post-anesthesia unit (PACU)
- Length of stay in PACU
- Delaying Hospital discharge All patients and their caregivers will be duly informed of the research objectives and will be included in the study only if they agree to participate and sign the Deed of Consent. The project was designed following the recommendations of Resolution 196/96 of the National Health Council and the Declaration of Helsinki for research involving human subjects (2000). In addition, the project was submitted to the Ethics Committee of the Hospital das Clinicas-UFPE and approved.
Patients will receive all information regarding the advantages and disadvantages of this technique, being safeguarded the right to refuse to participate. The researchers will undertake to publish the study, regardless of the outcome.
- Conditions
- Vomiting Postoperative
- Being tested
- Dexamethasone and ondasetron, Dexamethasone
- Keywords
- Nausea and Vomiting, Vomiting, Postoperative, Anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone and ondasetronDrug
Also called Decadron and nausedron
Patients will receive ondansetron (0.1 mg / kg dose of 4mg cap) associated with dexamethasone (0.15 mg / kg dose of 5mg ceiling) or dexamethasone (0.15 mg / kg) or placebo
DexamethasoneDrug
Also called Decadron
Children were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling)
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Placebo comparator | Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg) at the beginning of the procedure. Receives: Drug: Dexamethasone |
| Dexamethasone and ondasetron | Placebo comparator | Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling) and ondansetron (0.1 mg / kg dose of 4mg ceiling)at the beginning of the procedure. Receives: Drug: Dexamethasone and ondasetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative vomiting
Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.
Measured: The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone
Secondary outcomes (1)
delayed discharge
- Determine the relationship between the incidence of vomiting and the presence or absence of risk factors (duration ≥ 30 minutes of surgery, age ≥ 3 years and positive history in their own or relatives of postoperative vomiting).
- To determine the association between pain in the immediate postoperative period and the incidence of postoperative vomiting
- To determine the association between postoperative vomiting and delayed discharge
Measured: In-room post-anesthesia recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vomiting PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Investigators
- Flavia Orange, Investigator, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297010
- Sponsor's protocol ID
- 231/10
- Acronym
- vomiting
- Status last verified
- Jul 2011
- First submitted
- 15 Feb 2011
- Last updated
- 3 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled
- ClinicalTrials.gov ID
- NCT01297010
- Acronym / sponsor ID
- vomiting / 231/10
- Conditions
- Vomiting Postoperative
- Keywords
- Nausea and Vomiting, Vomiting, Postoperative, Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Feb 2011 (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 majority of pediatric surgery takes place in an outpatient basis. The occurrence of postoperative vomiting can lead to a delay in hospital discharge. However, the use of postoperative vomiting prophylaxis exposes patients unnecessarily to the drugs side effects and also raises the final costs of the surgical procedure. The Objective our study is Compare the incidence of postoperative vomiting between children who received dexamethasone, dexamethasone plus ondansetron or placebo for anti-emetic prophylaxis during outpatient surgery. This is a randomized, double blind, placebo-controlled study to comparing the use of dexamethasone, dexamethasone plus ondansetron and placebo for postoperative vomiting prophylaxis in children submitted to general anesthesia. Data analysis will be used is Fisher's exact test for the categorical variables and the Anova test for numerical variables as they presented Gaussian variation. The study used a significance level of 5%.
Detailed description
The investigators know that a large number of pediatric surgeries are performed on an outpatient basis and the occurrence of nausea and vomiting after surgery can lead to delayed discharge and increased hospital costs. Based on this fact, the investigators find it relevant to determine the incidence of postoperative vomiting in pediatric surgery patients to assess the need for antiemetic prophylaxis in this study population being developed in the surgical ward of the Hospital das Clinicas - Federal University of Pernambuco (HC-UFPE ).
The study will be conducted from March 2011 to September 2011.Pacientes pediatric ASA I and II underwent surgery in the pediatric surgical ward of the HC-UFPE.
The sample size calculation was performed in the program StatCalc Epi-Info 6.04d, based on data from relevant literature and determined the presence of 44 patients in each of the three groups, totaling 132 patients in the study.
Patients will be recruited in the preparation room anesthetic in surgical clinics of the Hospital for three shifts of existing pediatric surgery. After evaluation of each patient and then filled the criteria of inclusion and exclusion, those responsible will be informed about the procedures being undertaken and the possible consequences of their participation in research.
Only after signing an informed consent by the person responsible will be held the allocation of patients into three groups, after opening the sealed envelope containing the selected group for that participant. These envelopes are previously prepared by a person outside the research.
Therefore, the researcher has no prior knowledge of the group selected for the participant at the time of the consent solicitation.
At the end of the study will fill a flowchart with the profile of the trial, including the total number of patients, the number of eligible patients, the number of those who were offered participation in the study, the number of denied and his reason the number of patients who agreed to participate. The latter will be known only after statistical analysis Randomization to each specific group will be held in accordance with a table of random numbers previously generated computer (Random Allocation Software 1.0, 2004).
Independent variable
- Use of dexamethasone and ondansetron, or dexamethasone or placebo only
Dependent Variables
- Incidence of postoperative vomiting;
- The need for antiemetic therapy in the recovery room post-anesthesia unit (PACU)
- Length of stay in PACU
- Delaying Hospital discharge All patients and their caregivers will be duly informed of the research objectives and will be included in the study only if they agree to participate and sign the Deed of Consent. The project was designed following the recommendations of Resolution 196/96 of the National Health Council and the Declaration of Helsinki for research involving human subjects (2000). In addition, the project was submitted to the Ethics Committee of the Hospital das Clinicas-UFPE and approved.
Patients will receive all information regarding the advantages and disadvantages of this technique, being safeguarded the right to refuse to participate. The researchers will undertake to publish the study, regardless of the outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Placebo comparator | Drug: DexamethasoneChildren randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg) at the beginning of the procedure. |
| Dexamethasone and ondasetron | Placebo comparator | Drug: Dexamethasone and ondasetronChildren randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling) and ondansetron (0.1 mg / kg dose of 4mg ceiling)at the beginning of the procedure. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I or II
- Patients aged between 1 and 10 years old
- Patients undergoing general anesthesia for surgical repair of hernia, cryptorchidism and phimosis
Key exclusion criteria (6 listed)
- Officials who refused to sign the consent form
- ASA ≥ III
- History of allergy to dexamethasone and/or ondansetron
- Patients taking opioids preoperatively
- Patients using antiemetic drugs preoperatively
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 |
|---|---|---|
| Dexamethasone and ondasetronAlso: Decadron and nausedronPatients will receive ondansetron (0.1 mg / kg dose of 4mg cap) associated with dexamethasone (0.15 mg / kg dose of 5mg ceiling) or dexamethasone (0.15 mg / kg) or placebo | Drug | Dexamethasone and ondasetron |
| DexamethasoneAlso: DecadronChildren were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling) | Drug | Dexamethasone |
Primary outcome
Postoperative vomiting
Time frame: The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone
Compare the incidence of vomiting in children who received dexamethasone or dexamethasone combined with ondansetron or placebo for antiemetic prophylaxis in ambulatory surgery.
1 secondary outcome
delayed discharge
Time frame: In-room post-anesthesia recovery
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 3 Aug 2011.
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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.
Flavia Orange, Investigator principal investigator
Universidade Federal de Pernambuco
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and ondasetron and Dexamethasone in people with Vomiting Postoperative, run by Instituto Materno Infantil Prof. Fernando Figueira.
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 6 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 3 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Postoperative vomiting (time frame: The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone). 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 3 Aug 2011.