AnesthesiaPhase 3NCT04060771
Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery
A Phase 3 study testing Palonosetron and Dexamethasone in people with Anesthesia and Strabismus, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial summary
Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Anesthesia, Strabismus, PONV
- What is being tested?
- Palonosetron and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2018to 1 Jul 2020
- 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 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing elective strabismus surgery
- Physical state according to an American Society of Anesthesiologists (ASA) I and II
Who cannot join
- Children nor involved in surgery
- Participation in another study in the last month
- Previous history of PONV
- Occurrence of episodes of nausea or vomiting in the last 24 hours before surgery
- Chronic use of corticosteroids
- Previous history of motion sickness
Show all 9Show fewer
- Use of psychoactive drugs or any other medicine with an antiemetic effect;
- Known hypersensitivity to any study medication
- Severe diseases in organs such as kidney, liver, lung, heart, brain and bone marrow
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário Antonio Pedro
Niterói, Rio de Janeiro, 24033900
Júlio CA Moreira, Md
About this study
Official title: Prospective, Double-blind Study Comparing Palonosetron and Dexamethasone in the Prophylaxis of Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery
Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.
Read the detailed description
Prospective, double-blind study comparing Palonosetron and Dexamethasone in the prophylaxis of Post-Operative Nausea and Vomiting in children submitted to Strabismus surgery ABSTRACT Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.
Objective: The study aims to compare the incidence of PONV after intravenous administration of palonosetron or dexamethasone in pediatric patients undergoing elective strabismus surgery under general anesthesia.
Materials and Methods: This prospective, double-blind study consist of 80 patients of both genders, classified as ASA grade I and II, ranging in age from 2 to 15 years, scheduled for elective strabismus surgery at Hospital Universitário Antonio Pedro(HUAP), after consent by their parents. Patients will be randomized into two groups of 40 patients each. Group P will receive intravenous dose of palonosetron (1 mg.kg-1), and Group D will receive dexamethasone (0.2 mg.kg-1) after induction of anesthesia. Pacients will be observed for 6 hours before discharge and post-discharge symptoms will be assessed through telephone survey after 24 and 48 hours. At the end of the study, results will be compiled and statistical analysis will be done by using Mann-Whitney test, Chi-squared test and Fisher test.
- Conditions
- Anesthesia, Strabismus, PONV
- Being tested
- Palonosetron, Dexamethasone
- Keywords
- Anesthesia, Strabismus, PONV
- Medical subject headings
- Strabismus, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Also called Prophylactic
prophylaxis of postoperative nausea and vomiting
DexamethasoneDrug
Also called Prophylactic
prophylaxis of postoperative nausea and vomiting
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | During general anesthesia patients will receive a single intravenous dose of palonosetron 1 mcg.Kg-1. Receives: Drug: Palonosetron |
| Group D | Active comparator | During general anesthesia patients will receive a single intravenous dose of dexamethasone 0.2 mg.Kg-1. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.
Measured: 48 hours postoperative
Secondary outcomes (10)
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 24 hours after surgery.
Measured: 24 hours postoperative
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 6 hours after surgery.
Measured: 6 hours postoperative
Vomiting
Quantify the frequency of individual episodes of vomiting at the first 2 hours after surgery.
Measured: 2 hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 48 hours after surgery.
Measured: 48 hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 24 hours after surgery.
Measured: 24h hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 6 hours after surgery.
Measured: 6h hours postoperative
Nausea
Quantify the frequency of episodes of nausea at the first 2 hours after surgery.
Measured: 2h hours postoperative
Check adverse effects
Check the frequency of adverse events (headache, dizziness, drowsiness).
Measured: 48 hours postoperative
Treatment cost
Price evaluation of antiemetic drugs.
Measured: 48 hours postoperative
Response to medication
Quantify the number of complete responders (individuals who did not have an episode of PONV and did not require rescue medication).
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Aug 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Parallel groups
- Model description
- Patients will be divided between two groups, Group P will receive single dose of palonosetron whereas Group D will receive a single dose of dexamethasone during general anesthesia.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Rezende Assad, PhD, Universidade Federal Fluminense
- Investigators
- Júlio CA Moreira, MD, Principal investigator, Hospital Universitário Antonio Pedro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060771
- Sponsor's protocol ID
- Strabismus surgery
- Status last verified
- Aug 2019
- First submitted
- 18 Apr 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double-blind Study Comparing Palonosetron and Dexamethasone in the Prophylaxis of Post-Operative Nausea and Vomiting in Children Submitted to Strabismus Surgery
- ClinicalTrials.gov ID
- NCT04060771
- Acronym / sponsor ID
- Strabismus surgery
- Conditions
- Anesthesia, Strabismus, PONV
- Keywords
- Anesthesia, Strabismus, PONV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 19 Aug 2019 (actual)
- 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.
Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.
Detailed description
Prospective, double-blind study comparing Palonosetron and Dexamethasone in the prophylaxis of Post-Operative Nausea and Vomiting in children submitted to Strabismus surgery ABSTRACT Background: Postoperative nausea and vomiting (PONV) is one of the main causes of patient and family dissatisfaction, which may delay the onset of oral intake and postpone discharge. In pediatric patients, the incidence of PONV is high, and in some studies it can reach values of 70%. Strabismus surgery is considered an independent risk factor for PONV. Palonosetron is a second generation antiemetic drug, 5-hydroxytryptamine receptor antagonist, with a long half-life, which allows single dose administration and has been shown to be safe and effective in the treatment of chemotherapy induced nausea and vomiting, and has been used with satisfactory results in the prophylaxis of PONV in adult and pediatric patients. Studies involving palonosetron are still scarce.
Objective: The study aims to compare the incidence of PONV after intravenous administration of palonosetron or dexamethasone in pediatric patients undergoing elective strabismus surgery under general anesthesia.
Materials and Methods: This prospective, double-blind study consist of 80 patients of both genders, classified as ASA grade I and II, ranging in age from 2 to 15 years, scheduled for elective strabismus surgery at Hospital Universitário Antonio Pedro(HUAP), after consent by their parents. Patients will be randomized into two groups of 40 patients each. Group P will receive intravenous dose of palonosetron (1 mg.kg-1), and Group D will receive dexamethasone (0.2 mg.kg-1) after induction of anesthesia. Pacients will be observed for 6 hours before discharge and post-discharge symptoms will be assessed through telephone survey after 24 and 48 hours. At the end of the study, results will be compiled and statistical analysis will be done by using Mann-Whitney test, Chi-squared test and Fisher test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be divided between two groups, Group P will receive single dose of palonosetron whereas Group D will receive a single dose of dexamethasone during general anesthesia.
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Drug: PalonosetronDuring general anesthesia patients will receive a single intravenous dose of palonosetron 1 mcg.Kg-1. |
| Group D | Active comparator | Drug: DexamethasoneDuring general anesthesia patients will receive a single intravenous dose of dexamethasone 0.2 mg.Kg-1. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children undergoing elective strabismus surgery
- Physical state according to an American Society of Anesthesiologists (ASA) I and II
Key exclusion criteria (9 listed)
- Children nor involved in surgery
- Participation in another study in the last month
- Previous history of PONV
- Occurrence of episodes of nausea or vomiting in the last 24 hours before surgery
- Chronic use of corticosteroids
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 |
|---|---|---|
| PalonosetronAlso: Prophylacticprophylaxis of postoperative nausea and vomiting | Drug | Group P |
| DexamethasoneAlso: Prophylacticprophylaxis of postoperative nausea and vomiting | Drug | Group D |
Primary outcome
Vomiting
Time frame: 48 hours postoperative
Quantify the frequency of individual episodes of vomiting at the first 48 hours after surgery.
10 secondary outcomes
Vomiting
Time frame: 24 hours postoperative
Vomiting
Time frame: 6 hours postoperative
Vomiting
Time frame: 2 hours postoperative
Nausea
Time frame: 48 hours postoperative
Nausea
Time frame: 24h hours postoperative
Nausea
Time frame: 6h hours postoperative
Nausea
Time frame: 2h hours postoperative
Check adverse effects
Time frame: 48 hours postoperative
Treatment cost
Time frame: 48 hours postoperative
Response to medication
Time frame: 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
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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.
Júlio CA Moreira, MD principal investigator
Hospital Universitário Antonio Pedro
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 Palonosetron and Dexamethasone in people with Anesthesia and Strabismus, run by Universidade Federal Fluminense at 1 site in Brazil.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Aug 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra R Assad, MD, MSc, PhD (5521999859746, Alexandraassad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vomiting (time frame: 48 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 19 Aug 2019.