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Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

Primary Purpose

Tonsillitis, Tonsillectomy

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Sponsored by
Children's Healthcare of Atlanta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tonsillitis focused on measuring Pain Relief, Non-Narcotic Pain relief

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participants age 3-18 years
  • ASA class 1 or 2
  • elective Tonsillectomy/Adenoidectomy
  • outpatient setting.

Exclusion Criteria:

  • BMI >40kg/m2
  • history of renal insufficiency, chronic pain
  • allergy to gabapentin
  • history of developmental delay

Sites / Locations

  • Children's Healthcare of AtlantaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Group

Gabapentin Group

Arm Description

Participants will be randomized to either Control Group or Gabapentin Group

Participants will be randomized to either Control Group or Gabapentin Group

Outcomes

Primary Outcome Measures

Narcotic Consumption
To examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg(weight and height will be combined to report BMI in kg/m^2).

Secondary Outcome Measures

First Analgesic Timing
To record the time to first analgesic postoperatively
Pain Scale Scores
To compare the Wong- Baker FACES Pain Rating Scale and the 1-10 numeric pain distress scale pain scores at 12, 24 and 48 hours postoperatively. The 0-10 Numeric Pain Distress Pain Scale utilizes number gradations to describe pain for school age children and adolescents. A zero score means the absence of pain while a five describes distressing pain and a ten infers unbearable pain. As for the Wong-Baker FACES Scale, a series of faces can be shown to children over the age of three. The six faces depict facial expressions with zero-no hurt at all, one-hurts just a little bit, two-hurts a little more, three-hurts even more, four-hurts a whole lot, and five- hurts as much as you can imagine. No subscales will be used or combined.

Full Information

First Posted
July 20, 2018
Last Updated
July 23, 2019
Sponsor
Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT03625011
Brief Title
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy
Official Title
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Healthcare of Atlanta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this pilot study: 1) to examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg given 2) to record the time to first analgesic postoperatively and 3) to compare Wong Baker and the 0-10 numeric pain distress scale scores at 12, 24 and 48 hours postoperatively. We hypothesize one 15mg/kg (up to 600mg) dose of gabapentin will decrease mean narcotic amounts in mg/kg compared to participants who do not receive preoperative gabapentin and will demonstrate a decreased mean time to first analgesic as well as to lower mean pain scores for each age group at 12, 24 and 48 hours.
Detailed Description
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As from a regional healthcare organization. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively. Additionally, young children will receive instruction for Tylenol and Motrin postoperatively while teenagers will receive a narcotic prescription. Outcome measurements include: mean Tylenol mg/kg, Motrin mg/kg and narcotic mg/kg use. Additional measurements: Mean time to first analgesic. Phone interviews with the research nurse for three days postoperatively will elicit pain scores at 12, 24 and 48 hours postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis, Tonsillectomy
Keywords
Pain Relief, Non-Narcotic Pain relief

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized to either Control Group or Gabapentin Group
Arm Title
Gabapentin Group
Arm Type
Active Comparator
Arm Description
Participants will be randomized to either Control Group or Gabapentin Group
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.
Primary Outcome Measure Information:
Title
Narcotic Consumption
Description
To examine the use of gabapentin in reducing pain in the first 48 hours postoperatively including the total amount of narcotics mg/kg(weight and height will be combined to report BMI in kg/m^2).
Time Frame
First 48 hours postoperatively
Secondary Outcome Measure Information:
Title
First Analgesic Timing
Description
To record the time to first analgesic postoperatively
Time Frame
First 48 Hours postoperatively
Title
Pain Scale Scores
Description
To compare the Wong- Baker FACES Pain Rating Scale and the 1-10 numeric pain distress scale pain scores at 12, 24 and 48 hours postoperatively. The 0-10 Numeric Pain Distress Pain Scale utilizes number gradations to describe pain for school age children and adolescents. A zero score means the absence of pain while a five describes distressing pain and a ten infers unbearable pain. As for the Wong-Baker FACES Scale, a series of faces can be shown to children over the age of three. The six faces depict facial expressions with zero-no hurt at all, one-hurts just a little bit, two-hurts a little more, three-hurts even more, four-hurts a whole lot, and five- hurts as much as you can imagine. No subscales will be used or combined.
Time Frame
12, 24 and 48 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants age 3-18 years ASA class 1 or 2 elective Tonsillectomy/Adenoidectomy outpatient setting. Exclusion Criteria: BMI >40kg/m2 history of renal insufficiency, chronic pain allergy to gabapentin history of developmental delay
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beena Desai
Phone
404-785-2269
Email
beena.desai@choa.org
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret A Gettis, DNP,CPNP-PC
Phone
404-785-8622
Email
margaret.gettis@choa.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Calamaro, PhD, CPNP-PC
Organizational Affiliation
Institutional Review Board
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beena Desai
Phone
404-785-2269
Email
beena.desai@choa.org
First Name & Middle Initial & Last Name & Degree
Margaret A. Gettis, DNP,CPNP-PC
Phone
404-785-8622
Email
margaret.gettis@choa.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
26568937
Citation
Amani S, Abedinzadeh MR. Effects of Oral Gabapentin, Local Bupivacaine and Intravenous Pethidine on Post Tonsillectomy Pain. Iran J Otorhinolaryngol. 2015 Sep;27(82):343-8.
Results Reference
background
PubMed Identifier
25191179
Citation
Amin SM. Evaluation of gabapentin and dexamethasone alone or in combination for pain control after adenotonsillectomy in children. Saudi J Anaesth. 2014 Jul;8(3):317-22. doi: 10.4103/1658-354X.136417.
Results Reference
background
PubMed Identifier
25885382
Citation
Amin SM, Amr YM. Comparison between preemptive gabapentin and paracetamol for pain control after adenotonsillectomy in children. Anesth Essays Res. 2011 Jul-Dec;5(2):167-70. doi: 10.4103/0259-1162.94758.
Results Reference
background
PubMed Identifier
26404562
Citation
Hwang SH, Park IJ, Cho YJ, Jeong YM, Kang JM. The efficacy of gabapentin/pregabalin in improving pain after tonsillectomy: A meta-analysis. Laryngoscope. 2016 Feb;126(2):357-66. doi: 10.1002/lary.25636. Epub 2015 Sep 25.
Results Reference
background
PubMed Identifier
29030938
Citation
Knipper E, Banta-Green CJ, Jimenez N. Opioid use disorder and misuse: A review of the epidemiology and medical implications for pediatric anesthesiologists. Paediatr Anaesth. 2017 Nov;27(11):1070-1076. doi: 10.1111/pan.13225.
Results Reference
background
Citation
Mohamed, M.H., Al-Sercy, H. (2014). Preoperative gabapentin decreases the incidence of postoperative vomiting and analgesic requirements after pediatric adenotonsillectomy. The Egyptian Journal of Otolaryngology. 225-228.
Results Reference
background
PubMed Identifier
28697049
Citation
Thiels CA, Anderson SS, Ubl DS, Hanson KT, Bergquist WJ, Gray RJ, Gazelka HM, Cima RR, Habermann EB. Wide Variation and Overprescription of Opioids After Elective Surgery. Ann Surg. 2017 Oct;266(4):564-573. doi: 10.1097/SLA.0000000000002365.
Results Reference
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Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

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