A Phase 4 interventional study of Ketamine Hydrochloride in saline and Normal Saline (0.9% NaCl) in Postoperative Pain, Tonsillectomy and Adenotonsillectomy, sponsored by Hospital Universitario de Caracas. Completed at 1 site in Venezuela. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Hospital Universitario de Caracas · Phase 4, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 420 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Hospital Universitario de Caracas is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative gargle with 40 mg ketamine diluted in 30 mL saline, administered 5 minutes before induction of anesthesia.
Drug: Ketamine Hydrochloride in saline · Other: Normal Saline (0.9% NaCl)
Preoperative gargle with 30 mL normal saline administered 5 minutes before induction.
Drug: Ketamine Hydrochloride in saline · Other: Normal Saline (0.9% NaCl)
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.
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.
Postoperative pain intensity
Pain intensity measured using the Visual Analog Scale (VAS; 0-10) at predefined postoperative time points.
Time frame: 0, 4, 8, 12, and 24 hours postoperatively
Postoperative hemorrhage requiring surgical reintervention
Incidence of postoperative bleeding requiring return to the operating room for hemostasis.
Time frame: Within 24 hours postoperatively
Rescue analgesic consumption
Total requirement of additional analgesics (e.g., paracetamol or NSAIDs) within the first 24 hours after surgery.
Time frame: 24 hours postoperatively
Adverse events
Incidence of postoperative nausea and vomiting, sedation, or psychomimetic effects such as hallucinations or dysphoria.
Time frame: 24 hours postoperatively
Plan to share: 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.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario de Caracas