Chronic Pain Clinical Trial
Official title:
A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children
NCT number | NCT01675960 |
Other study ID # | 112909 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | July 2017 |
Verified date | July 2019 |
Source | Gillette Children's Specialty Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.
Status | Terminated |
Enrollment | 2 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Month to 16 Years |
Eligibility |
Inclusion Criteria: - male or female - 1 month to 16 years of age at enrollment - neurological impairment defined as subnormal (-2 S.D.) motor and/or cognitive ability from a variety of etiologies - chronic irritability defined as symptoms suggesting pain to the child's caregiver recurrently over a 4-week of greater time period - Subject must have an acceptable surrogate capable of giving consent on the subject's behalf Exclusion Criteria: - Children with resolved symptoms after treatment of identified sources of pain - Identified potential source of irritability without adequate trial of appropriate management - Ketogenic diet - Renal insufficiency or failure - Current treatment with gabapentin or pregabalin for another existing condition. |
Country | Name | City | State |
---|---|---|---|
United States | Gillette Children's Specialty Healthcare | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Gillette Children's Specialty Healthcare |
United States,
Breau LM, Camfield C, McGrath PJ, Rosmus C, Finley GA. Measuring pain accurately in children with cognitive impairments: refinement of a caregiver scale. J Pediatr. 2001 May;138(5):721-7. — View Citation
Breau LM, Camfield CS, McGrath PJ, Finley GA. Risk factors for pain in children with severe cognitive impairments. Dev Med Child Neurol. 2004 Jun;46(6):364-71. — View Citation
Breau LM, Camfield CS, McGrath PJ, Finley GA. The incidence of pain in children with severe cognitive impairments. Arch Pediatr Adolesc Med. 2003 Dec;157(12):1219-26. — View Citation
Breau LM, McGrath PJ, Camfield CS, Finley GA. Psychometric properties of the non-communicating children's pain checklist-revised. Pain. 2002 Sep;99(1-2):349-57. — View Citation
Greco C, Berde C. Pain management for the hospitalized pediatric patient. Pediatr Clin North Am. 2005 Aug;52(4):995-1027, vii-viii. Review. — View Citation
Hauer JM, Wical BS, Charnas L. Gabapentin successfully manages chronic unexplained irritability in children with severe neurologic impairment. Pediatrics. 2007 Feb;119(2):e519-22. — View Citation
Houlihan CM, O'Donnell M, Conaway M, Stevenson RD. Bodily pain and health-related quality of life in children with cerebral palsy. Dev Med Child Neurol. 2004 May;46(5):305-10. — View Citation
Perquin CW, Hazebroek-Kampschreur AA, Hunfeld JA, Bohnen AM, van Suijlekom-Smit LW, Passchier J, van der Wouden JC. Pain in children and adolescents: a common experience. Pain. 2000 Jul;87(1):51-8. — View Citation
Stallard P, Williams L, Lenton S, Velleman R. Pain in cognitively impaired, non-communicating children. Arch Dis Child. 2001 Dec;85(6):460-2. — View Citation
Zangen T, Ciarla C, Zangen S, Di Lorenzo C, Flores AF, Cocjin J, Reddy SN, Rowhani A, Schwankovsky L, Hyman PE. Gastrointestinal motility and sensory abnormalities may contribute to food refusal in medically fragile toddlers. J Pediatr Gastroenterol Nutr. 2003 Sep;37(3):287-93. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin. | We will determine whether gabapentin provides symptom relief for chronic irritability in neurologically impaired children, who continue to have irritability even though potential sources may have been identified and treated, or have sources that have not been identified. | Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). | |
Secondary | Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin. | We will attempt to identify gastrointestinal and sleep problems in neurologically impaired children with questionnaires given throughout the study. We hypothesize that gastrointestinal symptoms (feeding intolerance and symptoms associated with gas and bowel movements) and disrupted sleep are frequently associated with chronic irritability and will improve with gabapentin. | Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). |
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