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Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03625011
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Margaret Gettis, Children's Healthcare of Atlanta

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.

Condition or disease Intervention/treatment Phase
Tonsillitis Tonsillectomy Drug: Gabapentin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Participants will be randomized to either Control Group or Gabapentin Group
Drug: Gabapentin
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.
Other Name: Neurontin

Active Comparator: Gabapentin Group
Participants will be randomized to either Control Group or Gabapentin Group
Drug: Gabapentin
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.
Other Name: Neurontin




Primary Outcome Measures :
  1. Narcotic Consumption [ Time Frame: First 48 hours postoperatively ]
    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 :
  1. First Analgesic Timing [ Time Frame: First 48 Hours postoperatively ]
    To record the time to first analgesic postoperatively

  2. Pain Scale Scores [ Time Frame: 12, 24 and 48 hours postoperatively. ]
    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.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03625011


Contacts
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Contact: Beena Desai 404-785-2269 beena.desai@choa.org
Contact: Margaret A Gettis, DNP,CPNP-PC 404-785-8622 margaret.gettis@choa.org

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30329
Contact: Beena Desai    404-785-2269    beena.desai@choa.org   
Contact: Margaret A. Gettis, DNP,CPNP-PC    404-785-8622    margaret.gettis@choa.org   
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
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Study Chair: Christina Calamaro, PhD, CPNP-PC Institutional Review Board
  Study Documents (Full-Text)

Documents provided by Margaret Gettis, Children's Healthcare of Atlanta:
Informed Consent Form  [PDF] July 2, 2018


Publications:
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.

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Responsible Party: Margaret Gettis, Nurse Scientist, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT03625011     History of Changes
Other Study ID Numbers: IRB 18-052
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margaret Gettis, Children's Healthcare of Atlanta:
Pain Relief
Non-Narcotic Pain relief
Additional relevant MeSH terms:
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Tonsillitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents