An interventional study of Peritonsillar infiltration with ropivacaine and Peritonsillar infiltration with normal saline in Tonsillectomy, Ropivacaine and Analgesia, sponsored by University Hospital, Mahdia. Completed at 1 site in Tunisia. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University Hospital, Mahdia · Not applicable, Interventional, and Treatment
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.
University Hospital, Mahdia is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients will receive peritonsillar infiltration with normal saline
Other: Peritonsillar infiltration with normal saline · Drug: Normal Saline
patients will receive peritonsillar infiltration with ropivacaine
Other: Peritonsillar infiltration with ropivacaine · Drug: ropivacaine (local infiltration)
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.
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 0.9%, 5 mL, administered (2.5 mL per tonsillar bed)
Ropivacaine 0.2%, 5 mL, administered (2.5 mL per tonsillar bed)
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.
Time frame: From the end of surgery until 24 hours postoperatively
Intraoperative remifentanil dose (µg)
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.
Time frame: Perioperative.
Paracetamol Consumption at 24h
It refers to the total dose of paracetamol consumed in the first 24 hours postoperatively, normalized per kilogram of body weight (mg/kg).
Time frame: In the first 24 hours postoperatively
Time to first oral intake
Time from the end of surgery to the first oral intake, expressed in hours.
Time frame: 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
Postoperative pain intensity assessed using the Face, Legs, Activity, Cry, Consolability scale (FLACC), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: At 0, 2, 4, 8, 12 and 24 hours after surgery
Parental satisfaction
Parents' satisfaction was assessed using a 5-point Likert scale, where 1 indicated very dissatisfied, 5 very satisfied.
Time frame: At 24 hours after surgery
Incidence of adverse effects
Occurrence of adverse effects (hypotension, bradycardia, arrhythmia, or local anesthetic toxicity) during or after surgery.
Time frame: Perioperative.
Need for rescue tramadol
Once the FLACC score will be ≥ 4, rescue analgesia in the form of tramadol will be given.
Time frame: Perioperative.
Surgical conditions
It refers to the surgical dissection evaluated by the surgeon, easy, moderately easy or hard.
Time frame: Perioperative.
Intraoperative systolic blood pressure
It refers to the the systolic blood pressure collected intraoperatively every ten minutes.
Time frame: Perioperative.
Intraoperative diastolic blood pressure.
It refers to the diastolic blood pressure collected intraoperatively every ten minutes.
Time frame: Perioperative.
Intraoperative heart rate
It refers to the heart rate collected intraoperatively every ten minutes.
Time frame: Perioperative.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine
Agnosia
University Hospital, Mahdia