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Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children

NCT07825922 — Not applicable, Completed, 60 participants, University Hospital, Mahdia

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RegistryNCT07825922
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment60 (Actual)
SponsorUniversity Hospital, Mahdia (Other)
ConditionsTonsillectomy, Ropivacaine, Analgesia, Local Anesthesia, Children
InterventionsPeritonsillar infiltration with ropivacaine, Peritonsillar infiltration with normal saline, Normal Saline, ropivacaine (local infiltration) (Other, drug)
Datesstart 2024-03-01, primary completion 2024-09-30, completion 2024-09-30, first posted 2026-09-17, last updated 2026-09-17
Locations1 site in Tunisia

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-Summary

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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+Arms and interventions

ArmTypeInterventionsDescription
Group 1 (Placebo)Placebo comparatorOther: Peritonsillar infiltration with normal saline; Drug: Normal Salinepatients will receive peritonsillar infiltration with normal saline
Group 2 (Ropivacaine)Active comparatorOther: Peritonsillar infiltration with ropivacaine; Drug: ropivacaine (local infiltration)patients will receive peritonsillar infiltration with ropivacaine
  • 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)

+Outcome measures

Primary outcomes

  • Time to first postoperative analgesic request [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

  • Intraoperative remifentanil dose (µg) [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.
  • Paracetamol Consumption at 24h [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).
  • Time to first oral intake [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.
  • Face, Legs, Activity, Cry, Consolability scores over 24h [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).
  • Parental satisfaction [At 24 hours after surgery]: Parents' satisfaction was assessed using a 5-point Likert scale, where 1 indicated very dissatisfied, 5 very satisfied.
  • Incidence of adverse effects [Perioperative.]: Occurrence of adverse effects (hypotension, bradycardia, arrhythmia, or local anesthetic toxicity) during or after surgery.
  • Need for rescue tramadol [Perioperative.]: Once the FLACC score will be ≥ 4, rescue analgesia in the form of tramadol will be given.
  • Surgical conditions [Perioperative.]: It refers to the surgical dissection evaluated by the surgeon, easy, moderately easy or hard.
  • Intraoperative systolic blood pressure [Perioperative.]: It refers to the the systolic blood pressure collected intraoperatively every ten minutes.
  • Intraoperative diastolic blood pressure. [Perioperative.]: It refers to the diastolic blood pressure collected intraoperatively every ten minutes.
  • Intraoperative heart rate [Perioperative.]: It refers to the heart rate collected intraoperatively every ten minutes.

+Eligibility

Sex: All, ages: 3 Years to 6 Years

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

+Locations (1)

FacilityCityCountryStatus
Hôpital Taher SfarMahdiaTunisia

My Notes