Emergence AgitationPhase 3NCT07871266
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
A Phase 3 study testing Lidocaine and 0.9% Normal Saline in people with Emergence Agitation and Emergence Delirium, run by Assiut University.
Trial summary
Emergence agitation is a frequent recovery complication in young children following general anesthesia with sevoflurane. It is characterized by confusion, crying, disorientation, and non-purposeful thrashing during early wakefulness, and it occurs especially often following tonsillectomy due to surgical trauma and… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Emergence Agitation, Emergence Delirium, Postoperative Pain
- What is being tested?
- Lidocaine and 0.9% Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients scheduled for elective tonsillectomy operation
- Patients below 9 years of age
- American Society of Anesthesiologists (ASA) physical status I or II
- Written informed consent provided by a parent or legal guardian
Who cannot join
- Emergency surgical cases, including patients presenting with active tonsillar bleeding
- American Society of Anesthesiologists (ASA) physical status III or IV
- Known hypersensitivity or allergy to lidocaine, amide local anesthetics, or sevoflurane
- Pre-existing upper airway obstruction, active lower respiratory tract infection, or severe reactive airway disease
- Significant hepatic, renal, cardiac, or neurological disorders
About this study
Official title: Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy: A Randomized Controlled Double-Blinded Clinical Trial
Emergence agitation is a frequent recovery complication in young children following general anesthesia with sevoflurane. It is characterized by confusion, crying, disorientation, and non-purposeful thrashing during early wakefulness, and it occurs especially often following tonsillectomy due to surgical trauma and irritation in the upper airway. The primary aim of this clinical trial is to evaluate whether preoperative administration of nebulized lidocaine reduces the incidence and severity of emergence agitation compared to normal saline in pediatric patients undergoing elective tonsillectomy under sevoflurane anesthesia.
Participants are randomly allocated into two study groups in a 1:1 ratio:
Read more
- Group A (Lidocaine Group): Receives preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to 4 mL) administered via a nebulizer.
- Group B (Control Group): Receives preoperative inhalation of an identical volume (4 mL) of 0.9% normal saline placebo via a nebulizer.
Both groups receive a standardized sevoflurane-based general anesthetic. Emergence agitation is evaluated during the first 30 minutes following anesthesia cessation using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes evaluate postoperative pain severity (FLACC scale), rescue analgesic and sedative requirements, time to extubation, PACU length of stay, and airway-related or systemic complications.
- Conditions
- Emergence Agitation, Emergence Delirium, Postoperative Pain
- Being tested
- Lidocaine, 0.9% Normal Saline
- Keywords
- Nebulized Lidocaine, Lignocaine, Sevoflurane, Pediatric Anesthesia, Tonsillectomy, Pediatric Anesthesia Emergence Delirium (PAED), Airway Hyperreactivity
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lignocaine, 2% Preservative-Free Lidocaine, Nebulized Lidocaine
Preoperative administration of 2% preservative-free lidocaine at a dose of 2 to 4 mg/kg, diluted to a total volume of 4 mL, delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.
0.9% Normal SalineDrug
Preoperative administration of an identical volume of 4 mL of 0.9% normal saline delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Nebulized Lidocaine | Experimental | Patients in this arm receive preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to a total volume of 4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia. Receives: Drug: Lidocaine |
| Group B: Normal Saline Control | Placebo comparator | Patients in this arm receive preoperative inhalation of an identical volume of 0.9% normal saline (4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia. Receives: Drug: 0.9% Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Anesthesia Emergence Delirium (PAED) Scale Score
Evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale assesses 5 behavioral items: eye contact (0-4), purposeful actions (0-4), awareness of surroundings (0-4), restlessness (0-4), and consolability (0-4). Total scores range from 0 to 20, where higher scores indicate greater severity of emergence agitation/delirium.
Measured: 30 minutes after anesthesia discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seif Eldien AbdElbaset Abd Allah Khalil, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871266
- Sponsor's protocol ID
- Lignocaine for Agitation
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy: A Randomized Controlled Double-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT07871266
- Acronym / sponsor ID
- Lignocaine for Agitation
- Conditions
- Emergence Agitation, Emergence Delirium, Postoperative Pain
- Keywords
- Nebulized Lidocaine, Lignocaine, Sevoflurane, Pediatric Anesthesia, Tonsillectomy, Pediatric Anesthesia Emergence Delirium (PAED), Airway Hyperreactivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
Emergence agitation is a frequent recovery complication in young children following general anesthesia with sevoflurane. It is characterized by confusion, crying, disorientation, and non-purposeful thrashing during early wakefulness, and it occurs especially often following tonsillectomy due to surgical trauma and irritation in the upper airway. The primary aim of this clinical trial is to evaluate whether preoperative administration of nebulized lidocaine reduces the incidence and severity of emergence agitation compared to normal saline in pediatric patients undergoing elective tonsillectomy under sevoflurane anesthesia.
Participants are randomly allocated into two study groups in a 1:1 ratio:
- Group A (Lidocaine Group): Receives preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to 4 mL) administered via a nebulizer.
- Group B (Control Group): Receives preoperative inhalation of an identical volume (4 mL) of 0.9% normal saline placebo via a nebulizer.
Both groups receive a standardized sevoflurane-based general anesthetic. Emergence agitation is evaluated during the first 30 minutes following anesthesia cessation using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Secondary outcomes evaluate postoperative pain severity (FLACC scale), rescue analgesic and sedative requirements, time to extubation, PACU length of stay, and airway-related or systemic complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Nebulized Lidocaine | Experimental | Drug: LidocainePatients in this arm receive preoperative inhalation of 2% preservative-free lidocaine (2-4 mg/kg diluted to a total volume of 4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia. |
| Group B: Normal Saline Control | Placebo comparator | Drug: 0.9% Normal SalinePatients in this arm receive preoperative inhalation of an identical volume of 0.9% normal saline (4 mL) administered via nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients scheduled for elective tonsillectomy operation
- Patients below 9 years of age
- American Society of Anesthesiologists (ASA) physical status I or II
- Written informed consent provided by a parent or legal guardian
Key exclusion criteria (5 listed)
- Emergency surgical cases, including patients presenting with active tonsillar bleeding
- American Society of Anesthesiologists (ASA) physical status III or IV
- Known hypersensitivity or allergy to lidocaine, amide local anesthetics, or sevoflurane
- Pre-existing upper airway obstruction, active lower respiratory tract infection, or severe reactive airway disease
- Significant hepatic, renal, cardiac, or neurological disorders
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 |
|---|---|---|
| LidocaineAlso: Lignocaine, 2% Preservative-Free Lidocaine, Nebulized LidocainePreoperative administration of 2% preservative-free lidocaine at a dose of 2 to 4 mg/kg, diluted to a total volume of 4 mL, delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia. | Drug | Group A: Nebulized Lidocaine |
| 0.9% Normal SalinePreoperative administration of an identical volume of 4 mL of 0.9% normal saline delivered via inhalation using a nebulizer prior to elective tonsillectomy under standardized sevoflurane general anesthesia. | Drug | Group B: Normal Saline Control |
Primary outcome
Pediatric Anesthesia Emergence Delirium (PAED) Scale Score
Time frame: 30 minutes after anesthesia discontinuation
Evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale assesses 5 behavioral items: eye contact (0-4), purposeful actions (0-4), awareness of surroundings (0-4), restlessness (0-4), and consolability (0-4). Total scores range from 0 to 20, where higher scores indicate greater severity of emergence agitation/delirium.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine and 0.9% Normal Saline in people with Emergence Agitation and Emergence Delirium, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pediatric Anesthesia Emergence Delirium (PAED) Scale Score (time frame: 30 minutes after anesthesia discontinuation). 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 13 Oct 2026.