Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01839461
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2013-04-22
Brief Title:
Pharmacogenetic Morphine Spine Study
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Personalizing Perioperative Morphine Analgesia for Adolescents Undergoing Major Spine Surgeries
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to identify factors and genes the DNA material that determines the makeup of the human body that may be associated with how children cope with pain and respond to pain medication Morphine is a pain medication commonly prescribed after this surgery during the hospital stay The investigators want to study factors that may be associated with morphine requirement after surgery and side-effects from morphine They will use pharmacometric models to identify dosing guidelines and factors associated with individual variability in metabolism and efficacysafety of morphine They will also study psychological genetic and epigenetic factors associated with acute and chronic post-surgical pain after spine surgery The investigators expect that the information obtained in this research study will help to develop effective safer and tailored treatment options in the future
Detailed Description:
Safe and effective analgesia is an important unmet medical need in children Despite efforts to promote non-pharmacologic interventions drug treatment remains the standard of care for children experiencing severe pain following surgery Inadequate pain relief after invasive surgery and side effects from analgesics such as morphine occur frequently in up to 50 of children A study of patient-controlled analgesia morphine use after spine surgery in adolescents observed a 45 incidence of postoperative nausea and vomiting 15 incidence of pruritis and 7 incidence of respiratory depression Among the drugs available the opioids specifically morphine is the most commonly employed Morphine has a narrow therapeutic index with the most fatal toxicity being respiratory depression For morphine like most opioids there is a fine balance in dosing regimen between optimal pain control and safety in terms of decreasing morphines respiratory depressant sedative side effects Inadequate pain relief and analgesic side effects have major clinical behavioral and economic consequences Neither evidence-based dosing guidelines nor rigorous documentation of therapeutic benefit for morphine has been ascertained in the pediatric patient population Despite aggressive pain management after spine surgery findings showed that neither childrens pain nor their analgesic use diminished significantly over time As such there is a critical knowledge gap in the medical literature that significantly impacts the pediatric pain management In recognition of this therapeutic challenge the investigators plan to evaluate the determinants of inter-individual differences in opioid analgesic responsiveness and adverse effects in children Adolescents following spine surgery have a great variability in morphine requirements with greater use as they became older Analgesic dosing is dependent on appreciation of the interplay between pharmacokinetics pharmacodynamics and therapeutics These factors are often poorly understood where the effective control of procedural pain for example remains problematic Suitable pharmacological alternatives to opioid treatment for moderate to severe pain in children after surgery are limited and consequently there is a need for a critical evaluation of the existing opioids and research reports
Recently a number of small studies have shown the association of single nucleotide polymorphism in genes in the pain pathway with altered pain response to a stimulus or altered response to opioids following a painful procedure Age gender cultural influences anxiety type of surgical procedure and genetic factors can all influence the response By extending follow up of patients to years after surgery the aims were amended to include evaluation of chronic post-surgical outcomes
We will be collecting data on pain scores opioid effects psychological questionnaires blood samples and pupillometry data
Recently a number of small studies have shown the association of single nucleotide polymorphism in genes in the pain pathway with altered pain response to a stimulus or altered response to opioids following a painful procedure Age gender cultural influences anxiety type of surgical procedure and genetic factors can all influence the response By extending follow up of patients to years after surgery the aims were amended to include evaluation of chronic post-surgical outcomes
We will be collecting data on pain scores opioid effects psychological questionnaires blood samples and pupillometry data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None