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Completed

NCT Number: NCT04113720

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

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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Assiut governorate

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine hydrochloride

Drug

levobupivacaine 0.25%

Other names: levobupivacaine

Levobupivacaine Hydrochloride + Dexmedetomidine

Drug

Levobupivacaine plus Dexmedetomidine

Other names: levobupivacaine + precedex

Primary outcomes

  1. the first call for rescue analgesia

    Time frame: in 24 hours.

    pain assessment using the CHEOPS scale

Secondary outcomes

  1. The analgesics consumption

    Time frame: in 24 hours.

    The total analgesics consumption

  2. parental satisfaction

    Time frame: 24 hours

    a five-point Likert scale (1 - very dissatisfied, 2 - dissatisfied, 3 - neutral, 4 - satisfied, 5 - very satisfied).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 3, 2019
Registry last updated
Nov 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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