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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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)
Hôpital Taher Sfar
Mahdia, Tunisia
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.
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