Postoperative Nausea and VomitingPhase 4LETSVNNCT01986309
Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery
A Phase 4 study testing Lidocaine and Normal saline in people with Postoperative Nausea and Vomiting and Pain, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Pain
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChile
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 4
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 2 and 12 years
- ASA I or II
- Programmed for elective tonsillectomy with or without adenoidectomy under general anesthesia
Who cannot join
- Obesity, defined as body mass index (BMI) ≥ 95th percentile for age and sex.
- Use of antiemetic drugs during the 24 hours before surgery.
- Gastroesophageal reflux.
- History of allergy to any of the drugs used in the study.
- Down Syndrome.
Trial locations and contacts
1 site in 1 country.
Chile1 site
División de Anestesia - Facultad de Medicina Pontificia Universidad Católica
Santiago, Santiago Metropolitan, 8330024
About this study
Official title: Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.
Read the detailed description
The investigators want to know whether with intravenous lidocaine a adjunct for general anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or without adenoids has the same effect.
- Conditions
- Postoperative Nausea and Vomiting, Pain
- Being tested
- Lidocaine, Normal saline
- Keywords
- Postoperative, Nausea, Vomiting, Pain, Surgery
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h
Normal salineDrug
Also called Saline solution
Sodium Chloride 0.9% infusion
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Group L Lidocaine load dose 1.5 mg / kg over 5 minutes, followed by continuous infusion of 2 mg / kg / h, which is maintained until the end of surgical procedure Receives: Drug: Lidocaine |
| Group P | Placebo comparator | Normal saline solution administered under the same regimen Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo
Measured: 24 hours
Secondary outcomes (12)
The prevention of the composite "nausea / or vomiting"
Measured: 24 hours
Compare frequency of vomiting by baseline risk
Measured: 24 hours
Time to first vomiting
Measured: 24 hours
Time at which discharge criteria are met Postanesthesia care unit (PACU)
Measured: 24 hours
Length of stay in PACU unit
Measured: 24 hours
PACU opioid consumption
Measured: 24 hours
Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate
Measured: 24 hours
Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale
Measured: 24 hours
Time to first emetic drug administered
Measured: 24 hours
Type and number of doses of antiemetic drug required during hospitalization
Measured: 24 hours
Total length of stay
Measured: 24 hours
Analysis of cost-effectiveness.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando R Altermatt, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986309
- Sponsor's protocol ID
- PG 08-12
- Acronym
- LETSVN
- Status last verified
- Sep 2015
- First submitted
- 8 Jul 2013
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Echevarria GC, Altermatt FR, Paredes S, Puga V, Auad H, Veloso AM, Elgueta MF. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 May;35(5):343-348. doi: 10.1097/EJA.0000000000000807.
PubMed 29570108
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery, With or Without Adenoids
- ClinicalTrials.gov ID
- NCT01986309
- Acronym / sponsor ID
- LETSVN / PG 08-12
- Conditions
- Postoperative Nausea and Vomiting, Pain
- Keywords
- Postoperative, Nausea, Vomiting, Pain, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Nov 2013 (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.
There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.
Detailed description
The investigators want to know whether with intravenous lidocaine a adjunct for general anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or without adenoids has the same effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: LidocaineGroup L Lidocaine load dose 1.5 mg / kg over 5 minutes, followed by continuous infusion of 2 mg / kg / h, which is maintained until the end of surgical procedure |
| Group P | Placebo comparator | Drug: Normal salineNormal saline solution administered under the same regimen |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 2 and 12 years
- ASA I or II
- Programmed for elective tonsillectomy with or without adenoidectomy under general anesthesia
Key exclusion criteria (5 listed)
- Obesity, defined as body mass index (BMI) ≥ 95th percentile for age and sex.
- Use of antiemetic drugs during the 24 hours before surgery.
- Gastroesophageal reflux.
- History of allergy to any of the drugs used in the study.
- Down Syndrome.
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 |
|---|---|---|
| LidocaineBolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h | Drug | Group L |
| Normal salineAlso: Saline solutionSodium Chloride 0.9% infusion | Drug | Group P |
Primary outcome
Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo
Time frame: 24 hours
12 secondary outcomes
The prevention of the composite "nausea / or vomiting"
Time frame: 24 hours
Compare frequency of vomiting by baseline risk
Time frame: 24 hours
Time to first vomiting
Time frame: 24 hours
Time at which discharge criteria are met Postanesthesia care unit (PACU)
Time frame: 24 hours
Length of stay in PACU unit
Time frame: 24 hours
PACU opioid consumption
Time frame: 24 hours
Postoperative pain using Children and Infants Postoperative Pain Scale , face or Visual analogue Scale, as appropriate
Time frame: 24 hours
Postoperative agitation using Pediatric Anesthesia Emergence Delirium Scale
Time frame: 24 hours
Time to first emetic drug administered
Time frame: 24 hours
Type and number of doses of antiemetic drug required during hospitalization
Time frame: 24 hours
Total length of stay
Time frame: 24 hours
Analysis of cost-effectiveness.
Time frame: 24 hours
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 24 Sep 2015.
- Derived from this study: PubMed 29570108Echevarria GC, Altermatt FR, Paredes S, Puga V, Auad H, Veloso AM, Elgueta MF. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial. Eur J Anaesthesiol. 2018 May;35(5):343-348. doi: 10.1097/EJA.0000000000000807.
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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.
Fernando R Altermatt, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Normal saline in people with Postoperative Nausea and Vomiting and Pain, run by Pontificia Universidad Catolica de Chile 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 24 Sep 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluating the effectiveness of intravenous lidocaine during anesthesia to decrease the numbers of events (vomiting) during the immediate postoperative period up to 24 hours postoperatively, comparing to placebo (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986309, which also lists 1 linked publication.
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 24 Sep 2015.