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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05024825
Recruitment Status : Terminated (recruitment target not met.)
First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Farzana Afroze, Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Gabapentin Drug: hydrocodone, acetaminophen and ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : May 19, 2021
Actual Study Completion Date : May 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
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).
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.
Other Name: Neurontin

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.
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.
Other Name: no other intervention names applicable




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Medication Adverse Effect [ Time Frame: Through completion of the study. Time frame per subject is 7 days. ]
    Patient reported adverse effect to medications given



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024825


Locations
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United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
Albany Medical College
Additional Information:
Publications:

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Responsible Party: Farzana Afroze, Assistant Professor of Anesthesiology, Albany Medical College
ClinicalTrials.gov Identifier: NCT05024825    
Other Study ID Numbers: 4891
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Farzana Afroze, Albany Medical College:
tonsillectomy
gabapentin
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Ibuprofen
Gabapentin
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents