Pain | Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen
Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:gabapentinThe active comparator arm will receive gabapentin as per dosing specifics listed in the study arm description.
Drug:TramadolBoth study arms will receive tramadol per dosing details listed in the study arm descriptions.
Drug:IbuprofenBoth study arms will receive as needed (PRN) ibuprofen to take home.
Drug:PlaceboSimple syrup suspension
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Tramadol/gabapentin/ibuprofen(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
Tramadol/placebo/ibuprofen(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
Start Date: March 2014
Completed Date: February 2017
Phase: Phase 4
Primary Outcome: 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)
Secondary Outcome: 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)
Study sponsors, principal investigator, and references
Principal Investigator: Stefan J Friedrichsdorf, MD
Lead Sponsor: Children's Hospitals and Clinics of Minnesota