Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 19, 2021
Detailed 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.
Interventions
- Drug: Gabapentin
- 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.
- Drug: hydrocodone, acetaminophen and ibuprofen
- 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.
Arms, Groups and Cohorts
- Experimental: Gabapentin
- 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).
- Active Comparator: Hydrocodone
- 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.
Clinical Trial Outcome Measures
Primary Measures
- Total opioid equivalent dose
- Time Frame: Through completion of the study. Time frame per subject is 7 days.
- 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.
Secondary Measures
- Post operative pain score determined by Visual Analog Survey Scale
- Time Frame: Through completion of the study. Time frame per subject is 7 days.
- Pain severity, The pain VAS is a unidimensional measure of pain intensity. Scale ranges from 1-10. Score of 0 indicates no pain. Score of 1-3 indicates mild pain, score of 4-6 indicates moderate pain, score of 6 is severe pain, score of 7-9 is very severe pain, and a score of 10 is worst pain possible.
- Medication Adverse Effect
- Time Frame: Through completion of the study. Time frame per subject is 7 days.
- Patient reported adverse effect to medications given
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Albany Medical College
- Provider of Information About this Clinical Study
- Principal Investigator: Farzana Afroze, Assistant Professor of Anesthesiology – Albany Medical College
References
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