Back to resultsEffect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Primary Purpose
Pain, Postoperative
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
hydrocodone, acetaminophen and ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring tonsillectomy, gabapentin, postoperative pain
Eligibility 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.
Sites / Locations
- Albany Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gabapentin
Hydrocodone
Arm 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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Post operative pain score determined by Visual Analog Survey Scale
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
Patient reported adverse effect to medications given
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024825
Brief Title
Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Official Title
Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
recruitment target not met.
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
tonsillectomy, gabapentin, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm 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).
Arm Title
Hydrocodone
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
hydrocodone, acetaminophen and ibuprofen
Other Intervention Name(s)
no other intervention names applicable
Intervention 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.
Primary Outcome Measure Information:
Title
Total opioid equivalent dose
Description
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.
Time Frame
Through completion of the study. Time frame per subject is 7 days.
Secondary Outcome Measure Information:
Title
Post operative pain score determined by Visual Analog Survey Scale
Description
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.
Time Frame
Through completion of the study. Time frame per subject is 7 days.
Title
Medication Adverse Effect
Description
Patient reported adverse effect to medications given
Time Frame
Through completion of the study. Time frame per subject is 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
12. IPD Sharing Statement
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Links:
URL
https://www.samhsa.gov/data/sites/default/files/Revised2k11NSDUHSummNatFindings/Revised2k11NSDUHSummNatFindings/NSDUHresults2011.htm
Description
National Survey on Drug Use and Health: summary of national findings
URL
https://www.cdc.gov/nchs/nvss/deaths.htm
Description
National Vital Statistics System. Multiple cause of death file
URL
https://med.virginia.edu/pediatrics/wp-content/uploads/sites/237/2015/12/Feb16_Gabapentin_PedPharmaco.pdf
Description
Gabapentin Use in Postoperative and Neuropathic Pain in Children
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Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
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