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Trial record 8 of 452 for:    TRAMADOL

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

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ClinicalTrials.gov Identifier: NCT02076893
Recruitment Status : Terminated (Interim analysis results indicated need to recruit beyond scope of budget.)
First Posted : March 4, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota

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.

Condition or disease Intervention/treatment Phase
Pain Drug: gabapentin Drug: Tramadol Drug: Ibuprofen Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Comparison of Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen in Children Undergoing Tonsillectomy
Study Start Date : March 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Active Comparator: 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
Drug: gabapentin
The active comparator arm will receive gabapentin as per dosing specifics listed in the study arm description.
Other Name: Neurontin

Drug: Tramadol
Both study arms will receive tramadol per dosing details listed in the study arm descriptions.
Other Name: Ultram

Drug: Ibuprofen
Both study arms will receive as needed (PRN) ibuprofen to take home.
Other Names:
  • Advil
  • Motrin

Placebo Comparator: 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
Drug: Tramadol
Both study arms will receive tramadol per dosing details listed in the study arm descriptions.
Other Name: Ultram

Drug: Ibuprofen
Both study arms will receive as needed (PRN) ibuprofen to take home.
Other Names:
  • Advil
  • Motrin

Drug: Placebo
Simple syrup suspension




Primary Outcome Measures :
  1. 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) [ Time Frame: 10-day post-tonsillectomy recovery period ]
    To compare the efficacy of scheduled tramadol + PRN ibuprofen/tramadol vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen/tramadol 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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: 10-day post-tonsillectomy recovery period ]
    To evaluate the side effects of scheduled tramadol + PRN ibuprofen/tramadol vs. scheduled tramadol + scheduled gabapentin + PRN ibuprofen/tramadol 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.



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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076893


Locations
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United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
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Principal Investigator: Stefan J Friedrichsdorf, MD Childrens's Hospitals and Clinics of Minnesota

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Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT02076893     History of Changes
Other Study ID Numbers: CHC-IRGP-Gaba
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Children's Hospitals and Clinics of Minnesota:
Tonsillectomy
Pain management
Pediatrics
Additional relevant MeSH terms:
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Tramadol
Ibuprofen
Gabapentin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Analgesics, Opioid
Narcotics