Postoperative Tramadol/Gabapentin/Acetaminophen Versus Tramadol/Placebo/Acetaminophen
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Pain |
Intervention | Drug: gabapentin Drug: Tramadol Drug: Ibuprofen |
Phase | Phase 4 |
Sponsor | Children's Hospitals and Clinics of Minnesota |
Responsible Party | Children's Hospitals and Clinics of Minnesota |
ClinicalTrials.gov Identifier | NCT02076893 |
First Received | February 11, 2014 |
Last Updated | April 16, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | February 11, 2014 |
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Last Updated Date | April 16, 2014 |
Start Date | March 2014 |
Estimated Primary Completion Date | September 2016 |
Current Primary Outcome Measures | Efficacy of scheduled tramadol + PRN ibuprofen vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen [Time Frame: 10-day post-tonsillectomy recovery period] [Designated as safety issue: No]To compare the efficacy of scheduled tramadol + PRN ibuprofen vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen 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. |
Current Secondary Outcome Measures | Side effects of scheduled tramadol + PRN ibuprofen vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen [Time Frame: 10-day post-tonsollectomy recovery period] [Designated as safety issue: Yes]To evaluate the side effects of scheduled tramadol + PRN ibuprofen vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen during the post-tonsillectomy recovery period. Safety will be measured through use of a daily take-home diary that the parents fill out, and through phone calls made to parents by the study coordinator every two days during the 10-day recovery period. Specifically, parents will document, on a daily basis, number and occurence of any side effects (e.g., vomiting, dizziness), number of doctor and emergency room visits, length of stay in days (if applicable), and the purpose and location of any medical visits. |
Descriptive Information[ + expand ][ + ]
Brief Title | Postoperative Tramadol/Gabapentin/Acetaminophen Versus Tramadol/Placebo/Acetaminophen |
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Official Title | A Comparison of Postoperative Tramadol/Gabapentin/Acetaminophen Versus Tramadol/Placebo/Acetaminophen in Children Undergoing Tonsillectomy |
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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Pain |
Intervention | Drug: gabapentin The active comparator arm will receive gabapentin as per dosing specifics listed in the study arm description. Other Names: NeurontinDrug: Tramadol Both study arms will receive tramadol per dosing details listed in the study arm descriptions. Other Names: UltramDrug: Ibuprofen Both study arms will receive as needed (PRN) ibuprofen to take home. Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 84 |
Estimated Completion Date | September 2016 |
Estimated Primary Completion Date | March 2016 |
Eligibility 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 |
Gender | Both |
Ages | 4 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02076893 |
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Other Study ID Numbers | CHC-IRGP-Gaba |
Has Data Monitoring Committee | Yes |
Information Provided By | Children's Hospitals and Clinics of Minnesota |
Study Sponsor | Children's Hospitals and Clinics of Minnesota |
Collaborators | Not Provided |
Investigators | Principal Investigator: Stefan J Friedrichsdorf, MD Childrens's Hospitals and Clinics of Minnesota |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
Children's Hospitals and Clinics of Minnesota | Minneapolis, Minnesota, United States, 55404 Contact: Andrea C Postier, MPH | 612-813-6409 | andrea.postier@childrensmn.orgPrincipal Investigator: Stefan J Friedrichsdorf, MD Recruiting |
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