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.
ConditionPain
InterventionDrug: gabapentin
Drug: Tramadol
Drug: Ibuprofen
PhasePhase 4
SponsorChildren's Hospitals and Clinics of Minnesota
Responsible PartyChildren's Hospitals and Clinics of Minnesota
ClinicalTrials.gov IdentifierNCT02076893
First ReceivedFebruary 11, 2014
Last UpdatedApril 16, 2014
Last verifiedApril 2014

Tracking Information[ + expand ][ + ]

First Received DateFebruary 11, 2014
Last Updated DateApril 16, 2014
Start DateMarch 2014
Estimated Primary Completion DateSeptember 2016
Current Primary Outcome MeasuresEfficacy 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 MeasuresSide 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 TitlePostoperative Tramadol/Gabapentin/Acetaminophen Versus Tramadol/Placebo/Acetaminophen
Official TitleA 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
ConditionPain
InterventionDrug: 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:
  • Advil
  • Motrin
Study Arm (s)
  • Active Comparator: Tramadol/gabapentin/ibuprofen
    (A) Scheduled tramadol 1mg/kg Q6h [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
  • Placebo Comparator: tramadol/placebo/ibuprofen
    (A) Scheduled tramadol 1mg/kg Q6h [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

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment84
Estimated Completion DateSeptember 2016
Estimated Primary Completion DateMarch 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
GenderBoth
Ages4 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT02076893
Other Study ID NumbersCHC-IRGP-Gaba
Has Data Monitoring CommitteeYes
Information Provided ByChildren's Hospitals and Clinics of Minnesota
Study SponsorChildren's Hospitals and Clinics of Minnesota
CollaboratorsNot Provided
Investigators Principal Investigator: Stefan J Friedrichsdorf, MD Childrens's Hospitals and Clinics of Minnesota
Verification DateApril 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.org
Principal Investigator: Stefan J Friedrichsdorf, MD
Recruiting