Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy

NCT03625011 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB 18-052
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillitis; Tonsillectomy

Keywords

Pain Relief; Non-Narcotic Pain relief

Outcome Measures

Primary Outcomes (1)

• 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).

  First 48 hours postoperatively

Secondary Outcomes (2)

• First Analgesic Timing

  First 48 Hours postoperatively

• Pain Scale Scores

  12, 24 and 48 hours postoperatively.

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Participants will be randomized to either Control Group or Gabapentin Group

Drug: Gabapentin

Gabapentin Group

ACTIVE COMPARATOR

Participants will be randomized to either Control Group or Gabapentin Group

Drug: Gabapentin

Interventions

Gabapentin DRUG

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.

Also known as: Neurontin

Gabapentin Group; Placebo Group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 26568937 BACKGROUND

• 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.

  PMID: 25191179 BACKGROUND

• 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.

  PMID: 25885382 BACKGROUND

• 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.

  PMID: 26404562 BACKGROUND

• 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.

  PMID: 29030938 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28697049 BACKGROUND

MeSH Terms

Conditions

Tonsillitis

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Christina Calamaro, PhD, CPNP-PC

  Institutional Review Board

  STUDY CHAIR

Central Study Contacts

Beena Desai

CONTACT

404-785-2269; beena.desai@choa.org

Margaret A Gettis, DNP,CPNP-PC

CONTACT

404-785-8622; margaret.gettis@choa.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Scientist

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 10, 2018
• Study Start: July 31, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

US (1)