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Completed

NCT Number: NCT07825922

Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children

Tonsillectomy is one of the most frequently performed surgical procedures in children and is commonly associated with significant postoperative pain. Peritonsillar infiltration with local anesthetics such as Ropivacaine has been proposed to improve analgesia, but evidence remains inconsistent. This study aimed to evaluate the analgesic efficacy of peritonsillar Ropivacaine infiltration in pediatric tonsillectomy.

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Key information

Conditions

Tonsillectomy Agnosia Analgesia Children Local Anesthesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Ropivacaine Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Taher Sfar

Mahdia, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 3-6 years
  • classified as ASA I-II
  • scheduled for elective tonsillectomy without adenoidectomy

Exclusion criteria

  • systemic diseases (hepatic, renal, hematologic, or cardiac)
  • obesity (BMI ≥ 95th percentile)
  • upper respiratory infection within two weeks
  • chronic analgesic use
  • known allergy to local anesthetics

Treatment and study plan

Peritonsillar infiltration with ropivacaine

Other

Under general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with ropivacaine was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule.

Peritonsillar infiltration with normal saline

Other

Under general anesthesia and before surgical incision, the patient was positioned in Rose's position. Infiltration with normal saline was performed after intubation and before incision at three points (superior, middle, and inferior poles, including the posterior pillar), using a 23 gauge needle inserted between the pharyngeal muscles and tonsillar capsule.

normal saline

Drug

Normal saline 0.9%, 5 mL, administered (2.5 mL per tonsillar bed)

ropivacaine (local infiltration)

Drug

Ropivacaine 0.2%, 5 mL, administered (2.5 mL per tonsillar bed)

Primary outcomes

  1. Time to first postoperative analgesic request

    Time frame: From the end of surgery until 24 hours postoperatively

    Time from the end of surgery to the first administration of rescue analgesic medication. The time was recorded in hours.

Secondary outcomes

  1. Intraoperative remifentanil dose (µg)

    Time frame: Perioperative.

    It refers to the total dose of remifentanil administered to the patient during the entire surgical procedure. It reflects the amount of opioid used for intraoperative analgesia.

  2. Paracetamol Consumption at 24h

    Time frame: In the first 24 hours postoperatively

    It refers to the total dose of paracetamol consumed in the first 24 hours postoperatively, normalized per kilogram of body weight (mg/kg).

  3. Time to first oral intake

    Time frame: From the end of surgery until first oral intake, assessed during the first 24 hours after surgery.

    Time from the end of surgery to the first oral intake, expressed in hours.

  4. Face, Legs, Activity, Cry, Consolability scores over 24h

    Time frame: At 0, 2, 4, 8, 12 and 24 hours after surgery

    Postoperative pain intensity assessed using the Face, Legs, Activity, Cry, Consolability scale (FLACC), ranging from 0 (no pain) to 10 (worst possible pain).

  5. Parental satisfaction

    Time frame: At 24 hours after surgery

    Parents' satisfaction was assessed using a 5-point Likert scale, where 1 indicated very dissatisfied, 5 very satisfied.

  6. Incidence of adverse effects

    Time frame: Perioperative.

    Occurrence of adverse effects (hypotension, bradycardia, arrhythmia, or local anesthetic toxicity) during or after surgery.

  7. Need for rescue tramadol

    Time frame: Perioperative.

    Once the FLACC score will be ≥ 4, rescue analgesia in the form of tramadol will be given.

  8. Surgical conditions

    Time frame: Perioperative.

    It refers to the surgical dissection evaluated by the surgeon, easy, moderately easy or hard.

  9. Intraoperative systolic blood pressure

    Time frame: Perioperative.

    It refers to the the systolic blood pressure collected intraoperatively every ten minutes.

  10. Intraoperative diastolic blood pressure.

    Time frame: Perioperative.

    It refers to the diastolic blood pressure collected intraoperatively every ten minutes.

  11. Intraoperative heart rate

    Time frame: Perioperative.

    It refers to the heart rate collected intraoperatively every ten minutes.

Sponsors and collaborators

Lead sponsor

University Hospital, Mahdia

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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