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Pediatric Tonsillectomy
This case study represents an individual clinician experience with and methodology for using EXPAREL.
Pacira BioSciences, Inc., recognizes that there are other methodologies for administering local anesthetics, as well as individual patient considerations, when selecting the dose for a specific procedure.
Please see Important Safety Information below and refer to the Full Prescribing Information.
Disclosure: Dr Feldt is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Brent Feldt, MD
Affiliation
NorthBay Medical Center
Surgical Case Performed
Pediatric Tonsillectomy
Site of Care
Outpatient
PATIENT CHARACTERISTICS
Gender
Male
Age
8 years
Patient Weight
33 kg
Patient History
and Characteristics
and Characteristics
8-year-old male with history of snoring, witnessed breathing pauses during sleep, and excessive daytime fatigue.
PROCEDURAL DETAILS
Incision Size
Bilateral 2-cm oropharyngeal incision through the palatoglossus muscle and mucosa
Incision Type
Electrocautery
Preoperative Analgesics Used
Acetaminophen per rectum 480 mg (15 mg/kg)
Patient/Parent Education Regarding
Pain Management
Pain Management
Discussed with the patient and parents that a local anesthetic will be injected after the tonsils are removed into the area where the tonsils were located. This medication is not intended to replace the weight-based oral pain medication that is prescribed following surgery, but can help provide extended pain relief.
Needle Size
Single 5-mL syringe with 25-g needle
Dosing and Administration
- 33 kg x 4 mg/kg = 132 mg
- 132 mg ÷ 13.3 mg/mL = 9.9 mL of EXPAREL
(Please refer to the Dosing and Administration Guide for calculations.)*
*EXPAREL is available in 10-mL and 20-mL vials.
The recommended dose of EXPAREL for infiltration in adults is based on the size of the surgical site, the volume required to cover the area, and individual patient factors that may impact the safety of an amide local anesthetic. The maximum dose of EXPAREL should not exceed 266 mg. The recommended dose of EXPAREL for patients aged 6 to <17 years old is 4 mg/kg, up to a maximum of 266 mg. The recommended dose of EXPAREL in adults for interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal is 133 mg. The recommended dose of EXPAREL in adults for adductor canal block is 133 mg (10 mL) admixed with 50 mg (10 mL) of 0.5% bupivacaine HCl, for a total volume of 20 mL.
EXPAREL can be administered unexpanded (20 mL) or expanded to increase volume up to a total of 300 mL (final concentration of 0.89 mg/mL [ie, 1:14 dilution by volume]) with normal (0.9%) saline or lactated Ringer’s solution.
Bupivacaine HCl (which is approved for use in patients aged 12 and older) may be administered immediately before EXPAREL or admixed in the same syringe, as long as the ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2. Admixing may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. The toxic effects of these drugs are additive and their administration should be used with caution, including monitoring for neurological and cardiovascular effects related to local anesthetic systemic toxicity. Other than with bupivacaine, EXPAREL should not be admixed with other drugs prior to administration.
ASSESSED THE WEIGHT OF THE PATIENT, THE SURGICAL SITE, AND DEPTH OF TISSUE, THEN PREPARED INJECTION MATERIALS ACCORDINGLY
- For a 33-kg patient, the recommended dose (4 mg/kg) of EXPAREL® (bupivacaine liposome injectable suspension) is 132 mg, which is 9.9 mL of EXPAREL
- After tonsils were removed and homeostasis achieved, Dr Feldt assessed the surgical sites by palpating the tonsillar fossae to ensure no pulsations were palpable from the carotid artery or its branches
-
EXPAREL was administered as follows*:
- 2.5 mL administered into each mid-pole of the tonsillar fossae for a total of 5 mL to cover the tonsillar branch of the glossopharyngeal nerve
- 2.4 mL in each of the superior poles of the tonsillar fossae close to the incision site (4.8 mL total) to provide coverage of the incision site(s)
Step #1
EXPAREL is placed into a 5-mL syringe with a 25-g needle. 25-g needle marked at 1.0 cm to demonstrate the depth of needle insertion into the pharyngeal muscle. (See image at right)
Step #2
Dr Feldt inserts the 25-g needle into the midpole of each tonsillar fossae and aspirates to ensure no intravascular injection; then he injects with 2.5 mL of EXPAREL into each tonsillar fossae. (See image at right)
Step #3
Dr Feldt injects each bilateral incision site in the palatoglossus mucosa at the 1.0-cm needle depth with 2.4 mL of EXPAREL. (See image at right)
Step #4
Any bleeding from the injection sites is controlled with electrocautery.
*Total 9.9 mL.
- Postsurgical pain control with weight-based oral ibuprofen and acetaminophen was an effective adjunct with EXPAREL® (bupivacaine liposome injectable suspension) injection following tonsillectomy
-
Continuing the oral pain medication regimen and maintaining adequate hydration through 5 to 9 days following surgery helped patient maintain adequate oral intake
- Adequate oral intake is an important aspect to maintain saliva lubrication, reduce infection, and despite significant odynophagia following the procedure, can help reduce pain during the time exudates are shed from the tonsillar fossae
- Follow-up in 4 to 6 weeks following surgery to determine improvement in sleep patterns
Performed by: Dr. Selene G. Parekh
For more information, please reference the corresponding PDF .
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.
Important Notice
- This site is intended to provide medical and product information to health care professionals in the United States.
- To report an adverse event, email drugsafety@pacira.com or call 1-855-793-9727.
- For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-793-9727.
- These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.
Indication
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.
Important Safety Information
- EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
- Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
- Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
- Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
- EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, and/or pregnant patients.
- Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.
Warnings and Precautions Specific to EXPAREL
- Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
- EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
- The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.
Warnings and Precautions for Bupivacaine-Containing Products
- Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
- Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.
- Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
- Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
- Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.
Please refer to full Prescribing Information.
SEE MORE
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration
