Preemptive Genotyping and Pain Management
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01813695|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2013
Last Update Posted : February 5, 2016
|Condition or disease||Intervention/treatment|
|Pain||Procedure: Preemptive genotyping in medical record Procedure: Genotyping not included in electronic medical record|
|Study Type :||Observational|
|Estimated Enrollment :||748 participants|
|Observational Model:||Case Control|
|Official Title:||Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||April 2021|
Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
Procedure: Preemptive genotyping in medical record
Genetic sample taken but withheld from electronic medical record.
Procedure: Genotyping not included in electronic medical record
- Feasibility of PreEmptive Genotyping Testing [ Time Frame: From initial clinic visit to post-operative discharge, expected average of three months ]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.
- Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]Pain score (NRS 0 - 10) before and after each oral opioid dose (we will use time between the before and after pain score measures as a covariate)
- Analgesia Toxicity [ Time Frame: Admission for surgery, up to two weeks ]
- At least 1 documented ADR;
- Total number of documented ADRs;
- Total number of ADR related responses in "Pain Medicine Report" answered "sometimes" or "always";
- Total number of documented GI related ADRs - nausea (yes/no) and vomiting (yes/no);
- Total number of documented central nervous system (CNS) ADRs (Modified Ramsay scores > 4 and respiratory rate (RR) indicative of respiratory depression; and oxygen saturations (SpO2) < 90% on room air; and need for supplemental oxygen; and response of "always" for "Pain Medicine Report" question, "When you took the pain medicine, how often did it make you fall asleep?"
- Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]Participant related responses in "Pain Medicine Report"
- Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]Total number of rescue IV pain medication doses
- Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.
- Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]Total mg/kg 24hr dose of oral opioids
- Association between specific genotypes and pain sensitivity, reported postoperative pain, and opioid response [ Time Frame: Postoperative surgery, up to two weeks ]To explore association between specific genotypes (in addition to CYP2D6) and pain sensitivity, reported postoperative pain, and opioid response (pain reduction and incidence of adverse drug reactions (ADRs))
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813695
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Senthilkumar Sadhasivam, MD, MPH||Children's Hospital Medical Center, Cincinnati|