Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen

NCT02076893 | Terminated Phase 4 DMC

• 1 other identifier: CHC-IRGP-Gaba
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Tonsillectomy is the most common pediatric surgical procedure performed in the US, with over 530,000 procedures performed annually in children under 15 years (Baugh et al., 2011). The postoperative period can be particularly painful. A recent clinical consensus acknowledges there is no standard analgesic protocol, and calls for further research comparing postoperative pain medications (Baugh et al., 2011). Tramadol was found to be as effective as codeine with few reported side effects in a recent double-blinded, controlled trial conducted by the investigators at Children's Hospitals and Clinics (CHC), and it is currently being prescribed in the postoperative setting. However, despite its effectiveness for pain control, there were some children that continued to report pain during the 10-day follow-up period. In response, the investigators will conduct a randomized, double-blinded controlled trial to determine whether or not adding scheduled gabapentin to a scheduled tramadol + "as needed" (PRN) ibuprofen regimen provides better pain control than tramadol + ibuprofen PRN alone during the post-tonsillectomy period. Using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) (McGrath et al., 2008). This study will offer new information regarding the efficacy and side effects associated with adding scheduled gabapentin to a postoperative pain management protocol in a pediatric population.

Conditions

Pain

Keywords

Tonsillectomy; Pain management; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Efficacy of scheduled tramadol (days 1-5) + PRN ibuprofen (days 1-10)+ PRN tramadol (days 6-10) VS. scheduled tramadol (days 1-5) + scheduled gabapentin (days 1-5) + PRN ibuprofen (days 1-10) + PRN tramadol (days 6-10)

  To compare the efficacy of scheduled tramadol + PRN ibuprofen/tramadol vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen/tramadol for pain management during the post-tonsillectomy recovery period. Efficacy will be measured through daily collection of three pain scores (FACES or numeric; 0-10 rating): "pain right now," "typical pain over the past 24 hours," and "worst pain in the past 24 hours." Efficacy will also be measured daily with: 1) the Parents' Postoperative Pain Measure, 2) the number of times "as needed" medication is given by parents, 3) sleep quality, and 4) global satisfaction with pain management and recovery (on day 10 only). All efficacy measures will be recorded in a take-home diary by parents for 10 days postoperatively.

  10-day post-tonsillectomy recovery period

Secondary Outcomes (1)

• Side effects of scheduled tramadol (days 1-5) + PRN ibuprofen (days 1-10)+ PRN tramadol (days 6-10) VS. scheduled tramadol (days 1-5) + scheduled gabapentin (days 1-5) + PRN ibuprofen (days 1-10) + PRN tramadol (days 6-10)

  10-day post-tonsillectomy recovery period

Study Arms (2)

Tramadol/gabapentin/ibuprofen

ACTIVE COMPARATOR

(A) Scheduled tramadol 1mg/kg Q6h \[max. 50mg\] for 5 days; plus tramadol 1mg/kg Q6h PRN \[max. 50mg\] for 5 days (B) Scheduled gabapentin 3 mg/kg \[max 150 mg\] Q6h for 5 days (C) PRN ibuprofen 10 mg/kg \[max. 500 mg\] Q6h PRN

Drug: gabapentin; Drug: Tramadol; Drug: Ibuprofen

Tramadol/placebo/ibuprofen

PLACEBO COMPARATOR

(A) Scheduled tramadol 1mg/kg Q6h \[max. 50mg\] for 5 days; plus tramadol 1mg/kg Q6h PRN \[max. 50mg\] for 5 days (B) Scheduled placebo of same volume Q6h for 5 days (C) PRN ibuprofen 10 mg/kg \[max. 500 mg\] Q6h PRN

Drug: Tramadol; Drug: Ibuprofen; Drug: Placebo

Interventions

gabapentin DRUG

The active comparator arm will receive gabapentin as per dosing specifics listed in the study arm description.

Also known as: Neurontin

Tramadol/gabapentin/ibuprofen

Tramadol DRUG

Both study arms will receive tramadol per dosing details listed in the study arm descriptions.

Also known as: Ultram

Tramadol/gabapentin/ibuprofen; Tramadol/placebo/ibuprofen

Ibuprofen DRUG

Both study arms will receive as needed (PRN) ibuprofen to take home.

Also known as: Advil, Motrin

Tramadol/gabapentin/ibuprofen; Tramadol/placebo/ibuprofen

Placebo DRUG

Simple syrup suspension

Tramadol/placebo/ibuprofen

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child must be scheduled to undergo tonsillectomy (with or without adenoidectomy)
• Child must be between the ages of 4 and 15 at the time of enrollment.
• Child and caregiver must be English-speaking
• The same caregiver (e.g., mother) must agree to complete all study assessments with child to ensure consistency

You may not qualify if:

• Child cannot self-assess pain due to conditions such as developmental delays, chromosomal abnormalities, or other syndromes
• Child had significant adverse effects to tramadol, gabapentin and/or ibuprofen in the past
• Child has a known underlying seizure disorder (not febrile seizure)
• Child has known underlying renal or liver dysfunction (with creatinine, aspartate aminotransferase /alanine aminotransferase, more than twice above normal value for age, respectively)
• Child is taking an selective serotonin reuptake inhibitor (SSRI), norepinephrine reuptake inhibitor (SNRI), monoamine oxidase inhibitor (MAOI) or tricyclic

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Gabapentin; Tramadol; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System 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; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Phenylpropionates

Study Officials

• Stefan J Friedrichsdorf, MD

  Childrens's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)