Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients

Assiut University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Levobupivacaine; Post-tonsillectomy Analgesia

Treatments: Drug: Levobupivacaine hydrochloride; Drug: Levobupivacaine Hydrochloride + Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04113720

17300316

Details and patient eligibility

About

Tonsillectomy is one of the most common surgical performed procedures in children. Adenotonsillectomy surgery in pediatrics is commonly managed as an ambulatory surgery. This may be attributed to the use of the electro-dissection surgical technique that decreases the incidence of immediate postoperative hemorrhage. However, the use of the electro-cautery technique increases postoperative inflammation. Postoperative throat pain is a very important and significant problem because it can lead to decreased oral intake and dehydration with subsequent serious complications of dehydration.

Full description

The idea behind the use of local anesthetic agents in the peri-operative period is not only related to its ability to block peripheral nociceptor transmission after tissue damage but also in preventing sensitization of the central nervous system. Levobupivacaine is new, long-acting bupivacaine, amide-type local anesthetic and is thought to be less cardio and neurotoxic. However, few studies showed that local infiltration of levobupivacaine reduces the intensity of postoperative pain. Dexmedetomidine is a highly selective α2-adrenoceptor agonist recently introduced to anesthesia practice producing dose-dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites), without respiratory depression. Dexmedetomidine is being used off-label as an adjunctive agent in pediatric patients for sedation and analgesia; in the critical care unit, during non-invasive ( Magnetic resonance imaging) and invasive procedures ( cardiac catheterization and endoscopy). It may also decrease opioid usage and anesthesia requirements as seen from adult data prevent emergence delirium and postanesthesia shivering.

Enrollment: 90 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Weight: 10-40 kg
• American Society of Anesthesiologists ASA physical status: I-II.
• Operation: elective tonsillectomy (±adenoidectomy) in the otorhinolaryngology department, Assuit University Hospitals due to recurrent or chronic tonsillitis with or without adenoidectomy (using the surgical retraction and bipolar diathermy if indicated).

Exclusion criteria

• Patients having known hypersensitivity to dexmedetomidine or levobupivacaine.
• Patients with the following conditions: obstructive sleep apnea syndrome (whether confirmed by a polysomnography test or not), previous peritonsillar abscess formation and those with swallowing disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Group A

Experimental group

Description:

children will receive levobupivacaine 0.25% by peritonsillar infiltration after intubation 3- 5 min before the start of surgery.

Treatment:

Drug: Levobupivacaine hydrochloride

Group B

Active Comparator group

Description:

children will receive levobupivacaine 0.25% plus dexmedetomidine 1µg/kg diluted in 4 ml saline 0.9% and given by peritonsillar infiltration (2 ml per tonsil), after intubation 3- 5 min before the start of surgery.

Treatment:

Drug: Levobupivacaine Hydrochloride + Dexmedetomidine