Adenotonsillectomy, Postoperative Pain, Tonsillectomy
Conditions
Keywords
ketamine gargle, pediatric anesthesia, postoperative analgesia, NMDA receptor antagonist, opioid-sparing analgesia, airway surgery
Brief 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 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.
Interventions
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.
OTHERNormal 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.
Sponsors
Hospital Universitario de Caracas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care providers, investigators, and outcome assessors were blinded to group allocation. Study solutions were prepared by an independent pharmacist not involved in patient care or outcome assessment to ensure allocation concealment.
Intervention model description
Participants were randomized in a parallel 1:1 allocation to receive either a ketamine gargle or placebo prior to induction of anesthesia.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 4-12 years * ASA physical status I-II * Scheduled for elective adenotonsillectomy * Ability to gargle and spit the study solution
Exclusion criteria
* Known hypersensitivity to ketamine * Coagulation disorders * History of neuropsychiatric disease * Active upper respiratory tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | 0, 4, 8, 12, and 24 hours postoperatively | Pain intensity measured using the Visual Analog Scale (VAS; 0-10) at predefined postoperative time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative hemorrhage requiring surgical reintervention | Within 24 hours postoperatively | Incidence of postoperative bleeding requiring return to the operating room for hemostasis. |
| Rescue analgesic consumption | 24 hours postoperatively | Total requirement of additional analgesics (e.g., paracetamol or NSAIDs) within the first 24 hours after surgery. |
| Adverse events | 24 hours postoperatively | Incidence of postoperative nausea and vomiting, sedation, or psychomimetic effects such as hallucinations or dysphoria. |
Countries
Venezuela
Outcome results
None listed