Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
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| ClinicalTrials.gov Identifier: NCT05024825 |
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Recruitment Status :
Terminated
(recruitment target not met.)
First Posted : August 27, 2021
Last Update Posted : August 27, 2021
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Sponsor:
Albany Medical College
Information provided by (Responsible Party):
Farzana Afroze, Albany Medical College
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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 |
| 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 |
|---|---|
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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).
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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 |
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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.
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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 :
- 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 :
- 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
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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
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
Sponsors and Collaborators
Albany Medical College
Additional Information:
Publications:
Publications:
| 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 |
| 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:
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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 |