Upper Respiratory Tract InfectionsPhase 4NCT06584461
Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia
A Phase 4 study testing Lidocaine (drug) in people with Upper Respiratory Tract Infections and Perioperative Respiratory Complications, run by Tunis University at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. Read more about this study
- Who is it for?
- Ages 12 months to 14 years
- Conditions the study is for
- Upper Respiratory Tract Infections, Perioperative Respiratory Complications
- What is being tested?
- Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2023to 5 Feb 2024
- 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 12 months to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 to 14 years.
- American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
- Scheduled or urgent surgery or radiological exploration under general anesthesia.
- Upper respiratory tract infection (URTI) symptoms present for less than 15 days.
Who cannot join
- Refusal of participation by parents.
- Children on long-term corticosteroid or bronchodilator therapy.
- Contraindications to the use of lidocaine or other drugs used in the protocol.
- Patients who did not adhere to the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia: Interventional Controlled Randomized Double Blind Study
The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:
- Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
- What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.
- Being tested
- Lidocaine (drug), Saline (NaCl 0,9 %) (placebo)
- Keywords
- upper respiratory tract infections, IV lidocaine, General anesthesia, children, laryngospasm, bronchospasm, cough, perioperative respiratory complications
- Medical subject headings
- Respiratory Tract Infections, Laryngismus, Bronchial Spasm, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Drug
IV lidocaine, administered once during the induction of anesthesia.
Saline (NaCl 0,9 %) (placebo)Drug
IV placebo (normal saline), administered once during the induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group L: IV Lidocaine Group | Experimental | Participants in this group will receive a volume of weight*0.15 ml intravenous (IV) lidocaine at a dose of 1.5 mg/kg diluted to 10 mg/mL, administered at the induction of anesthesia.. Receives: Drug: Lidocaine (drug) |
| Group P: Placebo Group | Placebo comparator | Participants in this group will receive an intravenous placebo (normal saline solution), equivalent in volume (weight*0.15 ml) to the lidocaine group, administered at the induction of anesthesia. Receives: Drug: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Perioperative Respiratory Complications
Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room.
Measured: Within the first 2 hours post-operation.
Secondary outcomes (1)
Incidence of Side Effects Related to IV Lidocaine
Measure the occurrence of side effects such as nausea, vomiting, cardiac or neurological toxicity, and signs of anaphylaxis following the administration of IV lidocaine.
Measured: Within the first 24 hours post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start2 Jan 2023
- Primary completion31 Dec 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Trifa, Tunis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584461
- Sponsor's protocol ID
- 092023
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia: Interventional Controlled Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT06584461
- Acronym / sponsor ID
- 092023
- Keywords
- upper respiratory tract infections, IV lidocaine, General anesthesia, children, laryngospasm, bronchospasm, cough, perioperative respiratory complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 4 Sep 2024 (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.
The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:
- Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
- What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L: IV Lidocaine Group | Experimental | Drug: Lidocaine (drug)Participants in this group will receive a volume of weight*0.15 ml intravenous (IV) lidocaine at a dose of 1.5 mg/kg diluted to 10 mg/mL, administered at the induction of anesthesia.. |
| Group P: Placebo Group | Placebo comparator | Drug: Saline (NaCl 0,9 %) (placebo)Participants in this group will receive an intravenous placebo (normal saline solution), equivalent in volume (weight*0.15 ml) to the lidocaine group, administered at the induction of anesthesia. |
Who may qualify
- Ages
- 12 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 1 to 14 years.
- American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
- Scheduled or urgent surgery or radiological exploration under general anesthesia.
- Upper respiratory tract infection (URTI) symptoms present for less than 15 days.
Key exclusion criteria (4 listed)
- Refusal of participation by parents.
- Children on long-term corticosteroid or bronchodilator therapy.
- Contraindications to the use of lidocaine or other drugs used in the protocol.
- Patients who did not adhere to the study protocol.
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 |
|---|---|---|
| Lidocaine (drug)IV lidocaine, administered once during the induction of anesthesia. | Drug | Group L: IV Lidocaine Group |
| Saline (NaCl 0,9 %) (placebo)IV placebo (normal saline), administered once during the induction of anesthesia. | Drug | Group P: Placebo Group |
Primary outcome
Incidence of Perioperative Respiratory Complications
Time frame: Within the first 2 hours post-operation.
Measure the occurrence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation, bronchospasm) from the induction of anesthesia until discharge from the recovery room.
1 secondary outcome
Incidence of Side Effects Related to IV Lidocaine
Time frame: Within the first 24 hours post-operation.
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 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
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 4 study testing Lidocaine (drug) in people with Upper Respiratory Tract Infections and Perioperative Respiratory Complications, run by Tunis University at 1 site in Tunisia.
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 4 inclusion and 4 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 19 Sep 2024. 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 Tunisia. 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?
Incidence of Perioperative Respiratory Complications (time frame: Within the first 2 hours post-operation.). 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 Sep 2024.