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Comparison of the effects of dexmedetomidine and acetaminophen in tonsillectomy

Comparison of the effect of dexmedetomidine and acetaminophen on the level of analgesia, hemodynamic changes and postoperative complications in patients undergoing tonsillectomy.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250720066560N1
Enrollment
45
Registered
2025-09-03
Start date
2025-09-06
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conditions after pediatric tonsillectomy. Hypertrophy of tonsils

Interventions

Intervention 1: Intervention group: Group A (acetaminophen): For patients in this group, if the patients weight is less than 50 kg
the total dose of acetaminophen will be obtained based on the relationship of 15 mg/kg and if the patients weight is above 50 kg, the total dose of acetaminophen will be 1 gram. In this group, 1/3 of

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 13 Years

Inclusion criteria

Inclusion criteria: Being a candidate for tonsillectomy. Being at level 1 or 2 of the ASA classification criteria

Exclusion criteria

Exclusion criteria: Allergy to common anesthetic drugs Food allergies Severe seasonal allergies History of difficult anesthesia Specific illness or disability History of malignant hyperthermia in the patient or family members

Design outcomes

Primary

MeasureTime frame
Pain score on the CPOT scale. Timepoint: Patients' pain will be measured and recorded based on this criterion upon entry into recovery and then every 15 minutes until the end of recovery. Pain scores will be recorded every 30 minutes after exiting recovery for 2 hours. Method of measurement: This criterion consists of 4 parts. The first part is related to facial expression, the second part is related to body movements, the third part is related to ventilation conditions (in intubated patients) or speech status (in patients not requiring a ventilator), and the fourth part is related to the patient's muscle tone. Each of these parts has a score range of 0 to 2. According to this criterion, a score of 0 means no pain and a score of 8 means the most severe pain.;Hemodynamic changes: Mean arterial blood pressure and heart rate per minute monitored by the monitor. Timepoint: Upon entering the operating room, 10 minutes before induction of anesthesia, during induction of anesthesia, every 15 minutes during surgery, upon entering recovery, every 15 minutes until the end of recovery, and every 30 minutes until 2 hours after discharge from recovery. Method of measurement: Through monitoring the operating room, recovery room, and related departments.;Postoperative complications: nausea, vomiting, hallucinations, bleeding at the surgical site, laryngospasm, and bronchospasm. Timepoint: Measurements will be taken and recorded from the time the patient enters the post-anesthesia care unit until 2 hours after leaving the unit. Method of measurement: The occurrence of each of these side effects will be measured and recorded with a checklist that is written as the presence or absence of the side effect.;Need for additional postoperative pain relief: The patient's need for postoperative pain relief in the event of unbearable pain (patients who have a pain score higher than 3 based on the CPOT criteria and are confirmed by the anesthesiologist). Timepoint: Measurements will be taken a

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Bahramnejad

Kerman University of Medical Sciences

sarabahramnezhad98@gmail.com+98 34 3133 6730

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026