Preemptive Genotyping and Pain Management

NCT01813695 | Completed

• 2 other identifiers: 2013-0853NIH 3U01 HG006828-01S1
• Study Type: observational
• Target: 576
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Preemptive genetic testing; Pain; Pediatrics; Orthopedics; Pectus excavatum; Scoliosis

Outcome Measures

Primary Outcomes (1)

• Feasibility of PreEmptive Genotyping Testing

  The Investigator will use descriptive and summary statistics to determine the feasibility of preemptive CYP2D6 testing in children evaluated during a clinic visit for potential surgery.

  From initial clinic visit to post-operative discharge, expected average of three months

Secondary Outcomes (6)

• Analgesia Effectiveness

  Admission for surgery, up to two weeks

• Analgesia Toxicity

  Admission for surgery, up to two weeks

• Analgesia Effectiveness

  Admission for surgery, up to two weeks

• Analgesia Effectiveness

  Admission for surgery, up to two weeks

• Analgesia Effectiveness

  Admission for surgery, up to two weeks

Other Outcomes (1)

• Association between specific genotypes and pain sensitivity, reported postoperative pain, and opioid response

  Postoperative surgery, up to two weeks

Study Arms (2)

Preemptive

Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.

Procedure: Preemptive genotyping in medical record

Control

Genetic sample taken but withheld from electronic medical record.

Procedure: Genotyping not included in electronic medical record

Interventions

Preemptive genotyping in medical record PROCEDURE

Preemptive

Genotyping not included in electronic medical record PROCEDURE

Control

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (47)

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  PMID: 34029273 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Blood

MeSH Terms

Conditions

Pain; Funnel Chest; Scoliosis

Interventions

Medical Records; Electronic Health Records

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Curvatures; Spinal Diseases

Intervention Hierarchy (Ancestors)

Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Medical Records Systems, Computerized

Study Officials

• Senthilkumar Sadhasivam, MD, MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 19, 2013
• Study Start: March 1, 2013
• Primary Completion: November 4, 2020
• Study Completion: December 30, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)