Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy

Albany Medical College

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Gabapentin; Drug: hydrocodone, acetaminophen and ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT05024825

4891

Details and patient eligibility

About

This study aims to determine if administration of gabapentin preoperatively followed by a standing postoperative course is effective in reducing and possibly eliminating the use of opioid analgesics following this procedure. As a secondary outcome, it will evaluate the possible improvement in post tonsillectomy pain control with the use of a standing dose of gabapentin.

Full description

This is a prospective, randomized, non-blinded control trial designed to determine if administration of gabapentin postoperatively is effective in reducing and possibly eliminating the use of opioid analgesics following tonsillectomies in the adolescent population.

Enrollment: 17 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 12-18.
• Patient scheduled for elective tonsillectomy +/- adenoidec-tomy, +/- BMTs.
• ASA physical status I and II.

Exclusion criteria

• Severe upper respiratory tract infections.
• Patients who are actively on gabapentin or pregabalin, pre-existing with pain syndromes, chronic use of opioids, allergy to gabapentin, acetaminophen, and or NSAIDs
• Patient who lacks of fluency in English or inability to communicate pain.
• Patient who has severe asthma, bleeding disorders, and history of gastrointestinal bleeding, epilepsy, renal impairment or any other medical problem that in the opinion of the investigator would interfere with study population.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Gabapentin

Experimental group

Description:

Patients in the gabapentin group will receive gabapentin preoperatively, one time dose of 10 mg/kg PO (maximum dose 600 mg) and will resume scheduled doses postoperatively of PO gabapentin, 300 mg PO every 8 hours, in addition to acetaminophen and ibuprofen for 7 days postoperative. Acetaminophen 15mg/kg PO (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; gabapentin, 10 mg/kg standing every 8 hours (22).

Treatment:

Drug: Gabapentin

Hydrocodone

Active Comparator group

Description:

Patients in the hydrocodone group will receive scheduled doses of hydrocodone, acetaminophen and ibuprofen at scheduled doses. Acetaminophen 15mg/kg (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain.

Treatment:

Drug: hydrocodone, acetaminophen and ibuprofen