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

• Status: Terminated
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospitals and Clinics of Minnesota
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Ibuprofen; Tramadol

Criteria

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