Pain Management in Children and Young Adults With Sickle Cell Disease
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 1 - 20 |
| Updated: | 4/4/2019 |
| Start Date: | October 7, 2013 |
| End Date: | January 3, 2018 |
Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease
This is a phase II double-blind placebo-controlled clinical trial evaluating the effect of
gabapentin when added to standard pain management for patients with sickle cell disease
experiencing acute pain crisis in the ambulatory care setting.
Sickle cell pain is different for every patient. Some patients get complete relief from
routine pain medicines, and others need more time or more doses of pain medicines before the
pain goes away completely. It is known that humans have many types of pain, including
something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes)
has been treated successfully with a medicine called gabapentin. The investigators in this
study suspect that some sickle cell pain is a combination of pain types. They would like to
see if adding gabapentin to the usual pain medicines makes pain go away faster or more
completely.
Primary Objective:
- To assess the analgesic efficacy of gabapentin vs. placebo for pain during
vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response
to study drug will be defined by a decrease in pain score of ≥ 33% between presentation
to the acute care setting and assessment at 3 hours post administration of study drug.
Secondary Objective:
- To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC
between presentation to the acute care setting and assessment at 3 hours post
administration of study drug in the gabapentin vs. placebo groups.
gabapentin when added to standard pain management for patients with sickle cell disease
experiencing acute pain crisis in the ambulatory care setting.
Sickle cell pain is different for every patient. Some patients get complete relief from
routine pain medicines, and others need more time or more doses of pain medicines before the
pain goes away completely. It is known that humans have many types of pain, including
something called neuropathic pain. Neuropathic pain in other conditions (such as diabetes)
has been treated successfully with a medicine called gabapentin. The investigators in this
study suspect that some sickle cell pain is a combination of pain types. They would like to
see if adding gabapentin to the usual pain medicines makes pain go away faster or more
completely.
Primary Objective:
- To assess the analgesic efficacy of gabapentin vs. placebo for pain during
vaso-occlusive crisis (VOC) in participants with sickle cell disease (SCD). A response
to study drug will be defined by a decrease in pain score of ≥ 33% between presentation
to the acute care setting and assessment at 3 hours post administration of study drug.
Secondary Objective:
- To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC
between presentation to the acute care setting and assessment at 3 hours post
administration of study drug in the gabapentin vs. placebo groups.
Upon participant enrollment, study staff will randomize the participant to one of 2 possible
treatment arms: a single dose of gabapentin or a single dose of placebo. Morphine or other
opioid and non-steroidal anti-inflammatory drugs will be available to both groups as needed
for pain and will be administered according to the current standard of care for pain in VOC
from the Department of Hematology at St. Jude Children's Research Hospital (SJCRH).
Randomization will be performed in the SJCRH pharmacy by a pharmacist. The randomization will
be stratified by three age categories (1-3 years of age, 4-6 years, and 7 years or older) for
which distinct pain assessment tools are applied and for 2 pain score categories at
assessment at presentation (4-6 and 7-10, respectively). A block randomization with block
sizes varying randomly between 4 and 6 will be used in each stratum.
Pain scores will be obtained at presentation to the acute care setting and 3 hours (± 15
minutes) post administration of study drug. Participants who were discharged will be
contacted by study staff between 24 and 72 hours following administration of study drug to
see if there have been any side effects. Patients who were admitted after administration of
the study drug will be monitored through hospital record to determine if any unexpected
events occurred. After this follow up, participation in the study is complete.
treatment arms: a single dose of gabapentin or a single dose of placebo. Morphine or other
opioid and non-steroidal anti-inflammatory drugs will be available to both groups as needed
for pain and will be administered according to the current standard of care for pain in VOC
from the Department of Hematology at St. Jude Children's Research Hospital (SJCRH).
Randomization will be performed in the SJCRH pharmacy by a pharmacist. The randomization will
be stratified by three age categories (1-3 years of age, 4-6 years, and 7 years or older) for
which distinct pain assessment tools are applied and for 2 pain score categories at
assessment at presentation (4-6 and 7-10, respectively). A block randomization with block
sizes varying randomly between 4 and 6 will be used in each stratum.
Pain scores will be obtained at presentation to the acute care setting and 3 hours (± 15
minutes) post administration of study drug. Participants who were discharged will be
contacted by study staff between 24 and 72 hours following administration of study drug to
see if there have been any side effects. Patients who were admitted after administration of
the study drug will be monitored through hospital record to determine if any unexpected
events occurred. After this follow up, participation in the study is complete.
Inclusion Criteria:
- Participant must have sickle cell disease (any genotype) documented in the St. Jude
medical record.
- Participant must be seeking care for acute vaso-occlusive pain at St. Jude Children's
Research Hospital.
- Participant age must be ≥1 year and <21 years.
Exclusion Criteria:
- Prior randomization in this study.
- Mild pain (score <4) or pain for which treatment with opioid is not indicated.
- Pregnant or lactating female.
- Decreased glomerular filtration rate (GFT) (<60ml/min/1.73m^2) as estimated by the
revised Schwartz equation.
- Current treatment with gabapentinoid drugs (gabapentin or pregabalin).
- Known seizure disorder.
- Current treatment with antiepileptic agents.
- Pain in combination with other clinical symptoms that require additional
interventions, including fever with focus, acute chest syndrome, acute injury, or
splenic sequestration.
- Allergy to gabapentin.
- Current participation in another research study with an investigational new
drug/device (IND/IDE) agent.
- Inability or unwillingness of research participant or legal guardian/representative to
give written informed consent.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Doralina Anghelescu, MD
Phone: 866-278-5833
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