Preemptive Genotyping and Pain Management
|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
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|