Postoperative PainPhase 4KET-TONSILNCT07558044
Ketamine Gargle for Pain After Pediatric Tonsillectomy
A Phase 4 study testing Ketamine Hydrochloride in saline and Normal Saline (0.9% NaCl) in people with Postoperative Pain and Tonsillectomy, run by Hospital Universitario de Caracas at 1 site in Venezuela.
Trial summary
Post-tonsillectomy pain in children is a common and clinically significant problem that may lead to poor oral intake, dehydration, and delayed recovery. This study evaluates whether a simple preoperative intervention-gargling with ketamine-can reduce postoperative pain and improve recovery after pediatric… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Tonsillectomy, Adenotonsillectomy
- What is being tested?
- Ketamine Hydrochloride in saline and Normal Saline (0.9% NaCl)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteVenezuela
- Study dates
- 10 Jan 2024to 14 Jan 2025
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-12 years
- ASA physical status I-II
- Scheduled for elective adenotonsillectomy
- Ability to gargle and spit the study solution
Who cannot join
- Known hypersensitivity to ketamine
- Coagulation disorders
- History of neuropsychiatric disease
- Active upper respiratory tract infection
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Topical Ketamine for Post-Tonsillectomy Analgesia: A Randomized, Double-Blind, Placebo-Controlled Trial in Children
Post-tonsillectomy pain in children is a common and clinically significant problem that may lead to poor oral intake, dehydration, and delayed recovery. This study evaluates whether a simple preoperative intervention-gargling with ketamine-can reduce postoperative pain and improve recovery after pediatric adenotonsillectomy.
In this randomized, double-blind, placebo-controlled trial, 420 children aged 4 to 12 years undergoing elective adenotonsillectomy were assigned to receive either a ketamine gargle (40 mg in saline) or a saline placebo prior to anesthesia induction. Pain intensity was measured using the Visual Analog Scale at multiple time points within the first 24 hours after surgery. Secondary outcomes included postoperative bleeding requiring reintervention, analgesic consumption, and adverse events.
The study aims to determine whether topical ketamine provides effective and safe analgesia as part of an opioid-sparing strategy in pediatric airway surgery.
Read the detailed description
Adenotonsillectomy is one of the most frequently performed surgical procedures in pediatric patients and is associated with significant postoperative pain. Effective analgesia remains challenging due to the need to balance efficacy with safety, particularly avoiding opioid-related respiratory complications. Topical ketamine, a non-competitive NMDA receptor antagonist, has been proposed as a peripheral analgesic strategy capable of reducing nociceptive signaling without significant systemic effects.
This study was designed as a prospective, randomized, double-blind, placebo-controlled trial conducted at a tertiary care center. A total of 420 pediatric patients (ASA I-II, aged 4-12 years) scheduled for elective adenotonsillectomy were enrolled. Participants were randomized in a 1:1 ratio to receive either a ketamine gargle (40 mg diluted in 30 mL saline) or a placebo saline gargle administered 5 minutes before induction of anesthesia.
All patients underwent standardized anesthetic and surgical protocols to minimize confounding variables. Pain intensity was assessed using the Visual Analog Scale at 0, 4, 8, 12, and 24 hours postoperatively. Secondary outcomes included incidence of postoperative hemorrhage requiring surgical reintervention, total rescue analgesic consumption, and adverse events such as nausea, vomiting, sedation, or psychomimetic effects.
The primary objective was to evaluate the analgesic efficacy of preemptive topical ketamine. Secondary analyses explored its potential impact on postoperative morbidity, particularly bleeding events. This study was conducted in accordance with ethical standards and CONSORT guidelines.
- Conditions
- Postoperative Pain, Tonsillectomy, Adenotonsillectomy
- Being tested
- Ketamine Hydrochloride in saline, Normal Saline (0.9% NaCl)
- Keywords
- ketamine gargle, pediatric anesthesia, postoperative analgesia, NMDA receptor antagonist, opioid-sparing analgesia, airway surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hydrochloride in salineDrug
Ketamine gargle at a dose of 40mg diluted in 30 mL of normal saline, administered 5 minutes before induction of anesthesia. Patients were instructed to gargle the solution for 30 seconds and then expectorate.
Normal Saline (0.9% NaCl)Other
Placebo gargle consisting of 30 mL of normal saline, administered 5 minutes before induction of anesthesia. Patients were instructed to gargle the solution for 30 seconds and then expectorate.
| Study group | Role | What they receive |
|---|---|---|
| KETAMINE GROUP | Experimental | Preoperative gargle with 40 mg ketamine diluted in 30 mL saline, administered 5 minutes before induction of anesthesia. Receives: Drug: Ketamine Hydrochloride in saline; Other: Normal Saline (0.9% NaCl) |
| PLACEBO GROUP | Experimental | Preoperative gargle with 30 mL normal saline administered 5 minutes before induction. Receives: Drug: Ketamine Hydrochloride in saline; Other: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain intensity measured using the Visual Analog Scale (VAS; 0-10) at predefined postoperative time points.
Measured: 0, 4, 8, 12, and 24 hours postoperatively
Secondary outcomes (3)
Postoperative hemorrhage requiring surgical reintervention
Incidence of postoperative bleeding requiring return to the operating room for hemostasis.
Measured: Within 24 hours postoperatively
Rescue analgesic consumption
Total requirement of additional analgesics (e.g., paracetamol or NSAIDs) within the first 24 hours after surgery.
Measured: 24 hours postoperatively
Adverse events
Incidence of postoperative nausea and vomiting, sedation, or psychomimetic effects such as hallucinations or dysphoria.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start10 Jan 2024
- Primary completion7 Jan 2025
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a parallel 1:1 allocation to receive either a ketamine gargle or placebo prior to induction of anesthesia.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Caracas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Alejandro Veraza Almeida, Hospital Universitario de Caracas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558044
- Sponsor's protocol ID
- KET-AT-2024-01
- Acronym
- KET-TONSIL
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not yet been determined. Data may be made available upon reasonable request to the corresponding author following publication, in accordance with institutional policies and applicable ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Topical Ketamine for Post-Tonsillectomy Analgesia: A Randomized, Double-Blind, Placebo-Controlled Trial in Children
- ClinicalTrials.gov ID
- NCT07558044
- Acronym / sponsor ID
- KET-TONSIL / KET-AT-2024-01
- Conditions
- Postoperative Pain, Tonsillectomy, Adenotonsillectomy
- Keywords
- ketamine gargle, pediatric anesthesia, postoperative analgesia, NMDA receptor antagonist, opioid-sparing analgesia, airway surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Hospital Universitario de CaracasUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 30 Apr 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.
Post-tonsillectomy pain in children is a common and clinically significant problem that may lead to poor oral intake, dehydration, and delayed recovery. This study evaluates whether a simple preoperative intervention-gargling with ketamine-can reduce postoperative pain and improve recovery after pediatric adenotonsillectomy.
In this randomized, double-blind, placebo-controlled trial, 420 children aged 4 to 12 years undergoing elective adenotonsillectomy were assigned to receive either a ketamine gargle (40 mg in saline) or a saline placebo prior to anesthesia induction. Pain intensity was measured using the Visual Analog Scale at multiple time points within the first 24 hours after surgery. Secondary outcomes included postoperative bleeding requiring reintervention, analgesic consumption, and adverse events.
The study aims to determine whether topical ketamine provides effective and safe analgesia as part of an opioid-sparing strategy in pediatric airway surgery.
Detailed description
Adenotonsillectomy is one of the most frequently performed surgical procedures in pediatric patients and is associated with significant postoperative pain. Effective analgesia remains challenging due to the need to balance efficacy with safety, particularly avoiding opioid-related respiratory complications. Topical ketamine, a non-competitive NMDA receptor antagonist, has been proposed as a peripheral analgesic strategy capable of reducing nociceptive signaling without significant systemic effects.
This study was designed as a prospective, randomized, double-blind, placebo-controlled trial conducted at a tertiary care center. A total of 420 pediatric patients (ASA I-II, aged 4-12 years) scheduled for elective adenotonsillectomy were enrolled. Participants were randomized in a 1:1 ratio to receive either a ketamine gargle (40 mg diluted in 30 mL saline) or a placebo saline gargle administered 5 minutes before induction of anesthesia.
All patients underwent standardized anesthetic and surgical protocols to minimize confounding variables. Pain intensity was assessed using the Visual Analog Scale at 0, 4, 8, 12, and 24 hours postoperatively. Secondary outcomes included incidence of postoperative hemorrhage requiring surgical reintervention, total rescue analgesic consumption, and adverse events such as nausea, vomiting, sedation, or psychomimetic effects.
The primary objective was to evaluate the analgesic efficacy of preemptive topical ketamine. Secondary analyses explored its potential impact on postoperative morbidity, particularly bleeding events. This study was conducted in accordance with ethical standards and CONSORT guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a parallel 1:1 allocation to receive either a ketamine gargle or placebo prior to induction of anesthesia.
| Arm | Type | Receives |
|---|---|---|
| KETAMINE GROUP | Experimental | Drug: Ketamine Hydrochloride in saline, Other: Normal Saline (0.9% NaCl)Preoperative gargle with 40 mg ketamine diluted in 30 mL saline, administered 5 minutes before induction of anesthesia. |
| PLACEBO GROUP | Experimental | Drug: Ketamine Hydrochloride in saline, Other: Normal Saline (0.9% NaCl)Preoperative gargle with 30 mL normal saline administered 5 minutes before induction. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-12 years
- ASA physical status I-II
- Scheduled for elective adenotonsillectomy
- Ability to gargle and spit the study solution
Key exclusion criteria (5 listed)
- Known hypersensitivity to ketamine
- Coagulation disorders
- History of neuropsychiatric disease
- Active upper respiratory tract infection
- -
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 |
|---|---|---|
| Ketamine Hydrochloride in salineKetamine gargle at a dose of 40mg diluted in 30 mL of normal saline, administered 5 minutes before induction of anesthesia. Patients were instructed to gargle the solution for 30 seconds and then expectorate. | Drug | KETAMINE GROUP, PLACEBO GROUP |
| Normal Saline (0.9% NaCl)Placebo gargle consisting of 30 mL of normal saline, administered 5 minutes before induction of anesthesia. Patients were instructed to gargle the solution for 30 seconds and then expectorate. | Other | KETAMINE GROUP, PLACEBO GROUP |
Primary outcome
Postoperative pain intensity
Time frame: 0, 4, 8, 12, and 24 hours postoperatively
Pain intensity measured using the Visual Analog Scale (VAS; 0-10) at predefined postoperative time points.
3 secondary outcomes
Postoperative hemorrhage requiring surgical reintervention
Time frame: Within 24 hours postoperatively
Rescue analgesic consumption
Time frame: 24 hours postoperatively
Adverse events
Time frame: 24 hours postoperatively
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 5 May 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing has not yet been determined. Data may be made available upon reasonable request to the corresponding author following publication, in accordance with institutional policies and applicable ethical regulations.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 Ketamine Hydrochloride in saline and Normal Saline (0.9% NaCl) in people with Postoperative Pain and Tonsillectomy, run by Hospital Universitario de Caracas at 1 site in Venezuela.
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: finished, as of the sponsor's last update on 5 May 2026. 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 Venezuela. 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 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?
Postoperative pain intensity (time frame: 0, 4, 8, 12, and 24 hours postoperatively). 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 5 May 2026.