Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen
Status:
Terminated
Trial end date:
2017-02-01
Target enrollment:
Participant gender:
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.