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

NCT05024825 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: 4891
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

tonsillectomy; gabapentin; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total opioid equivalent dose

  The primary outcome variable will be the total opioid equivalent dose recorded over two weeks. The proposed study will test the null hypothesis that the two population (gabapentin and placebo) means are equal. The criterion for significance (alpha) has been set at 0.050. The test is 2-tailed, which means that an effect in either direction will be interpreted.

  Through completion of the study. Time frame per subject is 7 days.

Secondary Outcomes (2)

• Post operative pain score determined by Visual Analog Survey Scale

  Through completion of the study. Time frame per subject is 7 days.

• Medication Adverse Effect

  Through completion of the study. Time frame per subject is 7 days.

Study Arms (2)

Gabapentin

EXPERIMENTAL

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).

Drug: Gabapentin

Hydrocodone

ACTIVE COMPARATOR

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.

Drug: hydrocodone, acetaminophen and ibuprofen

Interventions

Gabapentin DRUG

Patients in the gabapentin arm may at any point call the Pediatric ENT clinic if pain is not adequately controlled. Patients will be prescribed hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14 yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain. Patients will be informed to stop taking gabapentin.

Also known as: Neurontin

Gabapentin

hydrocodone, acetaminophen and ibuprofen DRUG

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.

Also known as: no other intervention names applicable

Hydrocodone

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Related Publications (19)

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  PMID: 26404562 BACKGROUND

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Related Links

• National Survey on Drug Use and Health: summary of national findings
• National Vital Statistics System. Multiple cause of death file
• Gabapentin Use in Postoperative and Neuropathic Pain in Children

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin; Hydrocodone; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Phenylpropionates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 27, 2021
• Study Start: August 4, 2017
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

US (1)