- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01297010
Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children (vomiting)
Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA I or II
- Patients aged between 1 and 10 years old
- Patients undergoing general anesthesia for surgical repair of hernia, cryptorchidism and phimosis
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Dexamethasone
Children randomized to this group received a 10 ml syringe containing dexamethasone (0.15 mg / kg) at the beginning of the procedure.
|
Children were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling)
Other Names:
|
Placebo Comparator: Dexamethasone and ondasetron
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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The incidence of vomiting is seen in the anesthesia recovery room and 24 hours by phone
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
delayed discharge
Time Frame: In-room post-anesthesia recovery
|
|
In-room post-anesthesia recovery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Flavia Orange, Investigator, Universidade Federal de Pernambuco
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
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- 231/10
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.
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