Chronic Pain, Irritable Mood, Neurologically Impaired, Signs and Symptoms, Digestive, Sleeplessness
Conditions
Keywords
chronic irritability, chronic pain, Neurologically impaired, gabapentin
Brief summary
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.
Detailed description
This is a randomized, placebo-controlled, cross-over study design of the effects of gabapentin on chronic irritability in neurologically impaired children. The study will involve a 22 day medication titration, followed by a 7 day stable dosing period and a 6 day medication taper period. After an additional 3 day washout period, the subject will cross-over to the remaining arm of the study. Subjects will be evaluated for symptoms of chronic pain. Since the subjects are generally non-communicative, the subjects will be evaluated by two questionnaires and the Non-Communicating Children's Pain Checklist-Revised, to be completed by their parent or primary caregiver. The primary aim is to determine if gabapentin provides symptom relief for chronic irritability in neurologically impaired children.
Interventions
DRUGGabapentin
The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.
DRUGplacebo
The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.
Sponsors
Gillette Children's Specialty Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin. | Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin. | Compiled data reviewed at completion or withdrawal from study (3 months from beginning study). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin, Then Placebo Participants first receive gabapentin 3 times per day, with varying dosing based on the protocol. After 34-38 days, a washout period of 3 days occurs, before then receiving the placebo dose for 32 days. | 2 |
| Placebo, Then Gabapentin Participants first receive placebo 3 times per day. After 34-38 days, a washout period of 3 days occurs, before then receiving Gabapentin, with varying dosing based on the protocol, for 32 days. | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Gabapentin, Then Placebo | Total |
|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 1 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
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.
Time frame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).
Population: No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.
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.
Time frame: Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).
Population: No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.