Preoperative Gabapentin for Post-tonsillectomy Pain in Children

NCT01707420 | Completed Results

• 1 other identifier: 11-1687
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The typical post-operative course for children following surgical removal of their tonsils and adenoids can be challenging, especially for pain control. First line medications for pain include intravenous and enteral narcotics, acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) or N-methyl-D-aspartate (NMDA) antagonists but their effects appear to be short-lived. Gabapentin has been shown in adult studies to tone down the body's response to pain and decreases opioid use post-operatively. The purpose of this study is to see if a single preoperative dose will reduce post-operative pain scores and the amount of analgesic used.

Conditions

Post Operative Pain Management in Children With Tonsillectomy/Adenoidectomy

Keywords

pediatric pain; post operative pain; opioids; emergence agitation; preoperative anxiety; pharmacogenomics

Outcome Measures

Primary Outcomes (1)

• Total Oral Analgesia Consumption

  Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively.

  Up to 36 hours

Secondary Outcomes (2)

• Self-report Pain Score at Rest

  Up to 36 hours

• Self-report Pain Score When Swallowing

  Up to 36 hours

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

gabapentin, 20 mg/kg, single dose, 60 min prior to surgery

Drug: Gabapentin

liquid placebo

PLACEBO COMPARATOR

subjects randomized to the liquid placebo arm will receive a single dose elixir of 0.4 mL/kg given 60 min prior to surgery

Drug: liquid placebo

Interventions

Gabapentin DRUG

The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.

Also known as: Neurontin

Gabapentin

liquid placebo DRUG

Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.

liquid placebo

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• scheduled for outpatient tonsillectomy and adenoidectomy
• \< 60 Kg, between 5th and 95th percentile for weight
• ability to self-report pain
• complete pain diary with assistance from parent or guardian

You may not qualify if:

• require pre-anesthesia medication for anxiety
• require interpreter for verbal or written communication
• Obstructive sleep apnea significant enough to not qualify for outpatient surgery per surgeon
• ongoing oxygen dependence, pulmonary hypertension
• elevated risk of regurgitation
• history of seizures
• currently taking psychoactive medications or having a psychiatric condition requiring medications
• chronic pain disorders requiring medications
• renal disease
• developmental or cognitive disabilities
• history of adverse reactions to components of liquid gabapentin or placebo

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

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

Results Point of Contact

• Title: Thomas Notides
• Organization: University of Colorado

thomas.notides@childrenscolorado.org

720-777-6005

Study Officials

• Thomas Notides, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 15, 2021
• Results First Posted: January 15, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)