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

Levobupivacaine Clinical Trial

Official title:

The Effects of Levobupivacaine Versus Levobupivacaine Plus Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113720
• Other study ID #: 17300316
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 15, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laryngismus
• Levobupivacaine
• Post-tonsillectomy Analgesia

Intervention

Drug:
• Levobupivacaine hydrochloride
levobupivacaine 0.25%
• Levobupivacaine Hydrochloride + Dexmedetomidine
Levobupivacaine plus Dexmedetomidine

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Akoglu E, Akkurt BC, Inanoglu K, Okuyucu S, Dagli S. Ropivacaine compared to bupivacaine for post-tonsillectomy pain relief in children: a randomized controlled study. Int J Pediatr Otorhinolaryngol. 2006 Jul;70(7):1169-73. Epub 2006 Jan 18. — View Citation

Arbin L, Enlund M, Knutsson J. Post-tonsillectomy pain after using bipolar diathermy scissors or the harmonic scalpel: a randomised blinded study. Eur Arch Otorhinolaryngol. 2017 May;274(5):2281-2285. doi: 10.1007/s00405-017-4451-9. Epub 2017 Feb 17. — View Citation

Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. — View Citation

Karaaslan K, Yilmaz F, Gulcu N, Sarpkaya A, Colak C, Kocoglu H. The effects of levobupivacaine versus levobupivacaine plus magnesium infiltration on postoperative analgesia and laryngospasm in pediatric tonsillectomy patients. Int J Pediatr Otorhinolaryngol. 2008 May;72(5):675-81. doi: 10.1016/j.ijporl.2008.01.029. Epub 2008 Mar 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the first call for rescue analgesia	pain assessment using the CHEOPS scale	in 24 hours.
Secondary	The analgesics consumption	The total analgesics consumption	in 24 hours.
Secondary	parental satisfaction	a five-point Likert scale (1 - very dissatisfied, 2 - dissatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied).	24 hours