Analgesic Efficacy of Peritonsillar Ropivacaine Infiltration After Tonsillectomy in Children

NCT07825922 | Completed DMC

• 1 other identifier: CEM-2024-02-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tonsillectomy; Ropivacaine; Analgesia; Local Anesthesia; Children

Outcome Measures

Primary Outcomes (1)

• Time to first postoperative analgesic request

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

  From the end of surgery until 24 hours postoperatively

Secondary Outcomes (11)

• Intraoperative remifentanil dose (µg)

  Perioperative.

• Paracetamol Consumption at 24h

  In the first 24 hours postoperatively

• Time to first oral intake

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

• Face, Legs, Activity, Cry, Consolability scores over 24h

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

• Parental satisfaction

  At 24 hours after surgery

Study Arms (2)

Group 1 (Placebo)

PLACEBO COMPARATOR

patients will receive peritonsillar infiltration with normal saline

Other: Peritonsillar infiltration with normal saline; Drug: Normal Saline

Group 2 (Ropivacaine)

ACTIVE COMPARATOR

patients will receive peritonsillar infiltration with ropivacaine

Other: Peritonsillar infiltration with ropivacaine; Drug: ropivacaine (local infiltration)

Interventions

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.

Group 2 (Ropivacaine)

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.

Group 1 (Placebo)

Normal Saline DRUG

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

Group 1 (Placebo)

ropivacaine (local infiltration) DRUG

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

Group 2 (Ropivacaine)

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Mahdia: lead

Study Sites (1)

Hôpital Taher Sfar

Mahdia, Tunisia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant; Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The patients will be randomized to be allocated to 2 groups by a computer-generated randomization table into two equal groups

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 17, 2026
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

TU (1)