Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2020 |
| First Submitted: | 09/30/2019 |
| Estimated Enrollment Submitted: | 09/30/2019 |
| First Posted: | 10/02/2019 |
| Last Update Submitted: | 06/15/2020 |
| Last Update Posted: | 06/17/2020 |
| Actual Study Start Date: | 11/14/2019 |
| Estimated Primary Completion Date: | 07/31/2020 |
| Estimated Study Completion Date: | 08/31/2020 |
Condition or disease
Intervention/treatment
Drug: Group A
Drug: Group B
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Group A children will receive levobupivacaine 0.25% by peritonsillar infiltration after intubation 3- 5 min before the start of surgery. | Drug: Group A levobupivacaine 0.25% |
| Active Comparator: Group B 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. | Drug: Group B Levobupivacaine plus Dexmedetomidine |
Eligibility Criteria
| Ages Eligible for Study | 3 Years To 3 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. the first call for rescue analgesia [every 6 hours for the first 24 hours]
Secondary Outcome Measures
1. The analgesics consumption [in 24 hours.]
