Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
576 participants
Study Classification
OBSERVATIONAL
Study Start Date
2013-03-31
Study Completion Date
2022-12-30
Brief Summary
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The purpose of this study is to see if testing for genes related to pain and pain management before surgery affects how patients are treated for pain after surgery. The investigators want to know if this information will be used to effectively treat patients for pain after surgery if the clinical staff have a chance to review it before the surgery.
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Detailed Description
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Purpose: To determine the feasibility of preemptive (preoperative) cytochrome P450 isoenzyme (CYP2D6) testing and the variability of clinical measures (postoperative) in children whose opioid selection and dosing is influenced by preemptive CYP2D6 testing compared to children whose pain management does not include CYP2D6 preemptive testing. Results from this pilot study will inform a future study investigating the utility of preemptive pharmacogenomic testing in children at risk for requiring inpatient acute pain management with opioids.
Conditions
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Pain
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Preemptive
Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
Preemptive genotyping in medical record
Intervention Type
PROCEDURE
Control
Genetic sample taken but withheld from electronic medical record.
Genotyping not included in electronic medical record
Intervention Type
PROCEDURE
Interventions
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Preemptive genotyping in medical record
Intervention Type
PROCEDURE
Genotyping not included in electronic medical record
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Children, 6-17 years of age and adults, 18 - 21 years with idiopathic scoliosis and/or pectus excavatum scheduled for surgical clinic visit
* BMI \< 30
* Cognitively able to use a 0 - 10 numerical rating scale (NRS) to report level of pain
* Parents give permission (and children give assent when appropriate) or adult participants give consent for CYP2D6 results to be placed in Cincinnati Children's Hospital Medical Center (CCHMC's) EPIC
* BMI \< 30
* Cognitively able to use a 0 - 10 numerical rating scale (NRS) to report level of pain
* Parents give permission (and children give assent when appropriate) or adult participants give consent for CYP2D6 results to be placed in Cincinnati Children's Hospital Medical Center (CCHMC's) EPIC
Exclusion Criteria
* • Who had prior surgery for idiopathic scoliosis and/or pectus excavatum
* Who have prior CYP2D6 testing or Genetic Pharmacology Service (GPS) Psychiatry Panel documented in EPIC
* Who are taking prescription medication known to inhibit or induce CYP2D6
* Who are taking prescription medication known to inhibit (e.g. voriconazole) or induce (e.g. carbamazepine and rifampin) CYP3A4
* Who have liver or renal failure
* Who have history of narcotic abuse
* Who have prior CYP2D6 testing or Genetic Pharmacology Service (GPS) Psychiatry Panel documented in EPIC
* Who are taking prescription medication known to inhibit or induce CYP2D6
* Who are taking prescription medication known to inhibit (e.g. voriconazole) or induce (e.g. carbamazepine and rifampin) CYP3A4
* Who have liver or renal failure
* Who have history of narcotic abuse
Minimum Eligible Age
6 Years
Maximum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Senthilkumar Sadhasivam, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Site Status
Countries
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United States
References
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Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017.
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BACKGROUND
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Joshi GP, Kehlet H, Rawal N; PROSPECT Working Group. Evidence-based guidelines for postoperative pain management. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):173. doi: 10.1016/j.rapm.2006.11.002. No abstract available.
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Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
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Raja SN, Jensen TS. Predicting postoperative pain based on preoperative pain perception: are we doing better than the weatherman? Anesthesiology. 2010 Jun;112(6):1311-2. doi: 10.1097/ALN.0b013e3181dcd5cc. No abstract available.
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White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
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Kim H, Ramsay E, Lee H, Wahl S, Dionne RA. Genome-wide association study of acute post-surgical pain in humans. Pharmacogenomics. 2009 Feb;10(2):171-9. doi: 10.2217/14622416.10.2.171.
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BACKGROUND
Skorpen F, Laugsand EA, Klepstad P, Kaasa S. Variable response to opioid treatment: any genetic predictors within sight? Palliat Med. 2008 Jun;22(4):310-27. doi: 10.1177/0269216308089302.
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BACKGROUND
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BACKGROUND
Food and Drug Administration. FDA Drug Safety Communication: Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. http://wwwfdagov/Drugs/DrugSafety/ucm313631htm. Accessed 8/15/2012August 15, 2012
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Magnani B, Evans R. Codeine intoxication in the neonate. Pediatrics. 1999 Dec;104(6):e75. doi: 10.1542/peds.104.6.e75.
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Voronov P, Przybylo HJ, Jagannathan N. Apnea in a child after oral codeine: a genetic variant - an ultra-rapid metabolizer. Paediatr Anaesth. 2007 Jul;17(7):684-7. doi: 10.1111/j.1460-9592.2006.02182.x.
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BACKGROUND
Ciszkowski C, Madadi P, Phillips MS, Lauwers AE, Koren G. Codeine, ultrarapid-metabolism genotype, and postoperative death. N Engl J Med. 2009 Aug 20;361(8):827-8. doi: 10.1056/NEJMc0904266. No abstract available.
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BACKGROUND
Hermanns-Clausen M, Weinmann W, Auwarter V, Ferreiros N, Trittler R, Muller C, Pahl A, Superti-Furga A, Hentschel R. Drug dosing error with drops: severe clinical course of codeine intoxication in twins. Eur J Pediatr. 2009 Jul;168(7):819-24. doi: 10.1007/s00431-008-0842-7. Epub 2008 Oct 21.
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BACKGROUND
Lalovic B, Phillips B, Risler LL, Howald W, Shen DD. Quantitative contribution of CYP2D6 and CYP3A to oxycodone metabolism in human liver and intestinal microsomes. Drug Metab Dispos. 2004 Apr;32(4):447-54. doi: 10.1124/dmd.32.4.447.
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BACKGROUND
Zwisler ST, Enggaard TP, Mikkelsen S, Brosen K, Sindrup SH. Impact of the CYP2D6 genotype on post-operative intravenous oxycodone analgesia. Acta Anaesthesiol Scand. 2010 Feb;54(2):232-40. doi: 10.1111/j.1399-6576.2009.02104.x. Epub 2009 Aug 31.
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Sadhasivam S, Myer CM 3rd. Preventing opioid-related deaths in children undergoing surgery. Pain Med. 2012 Jul;13(7):982-3; author reply 984. doi: 10.1111/j.1526-4637.2012.01419.x. Epub 2012 Jun 13.
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Ramsay MA. Anesthesia and pain management at Baylor University Medical Center. Proc (Bayl Univ Med Cent). 2000 Apr;13(2):151-65. doi: 10.1080/08998280.2000.11927660. No abstract available.
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Paqueron X, Lumbroso A, Mergoni P, Aubrun F, Langeron O, Coriat P, Riou B. Is morphine-induced sedation synonymous with analgesia during intravenous morphine titration? Br J Anaesth. 2002 Nov;89(5):697-701.
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Whitlock MC. Combining probability from independent tests: the weighted Z-method is superior to Fisher's approach. J Evol Biol. 2005 Sep;18(5):1368-73. doi: 10.1111/j.1420-9101.2005.00917.x.
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Packiasabapathy S, Zhang X, Ding L, Aruldhas BW, Pawale D, Sadhasivam S. Quantitative Pupillometry as a Predictor of Pediatric Postoperative Opioid-Induced Respiratory Depression. Anesth Analg. 2021 Oct 1;133(4):991-999. doi: 10.1213/ANE.0000000000005579.
Reference Type
DERIVED
Other Identifiers
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NIH 3U01 HG006828-01S1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2013-0853
Identifier Type: -
Identifier Source: org_study_id
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