IP Library › Granted Patent US 12,077,821
Granted Patent B2
US 12,077,821 · App. 16/946,399 · Granted Sep 3, 2024

Personalized pain management and anesthesia: preemptive risk identification and therapeutic decision support

Inventors: Senthilkumar Sadhasivam (Mason, OH); Vidya Chidambaran (Cincinnati, OH); John McAuliffe (Cincinnati, OH); Kejian Zhang (Cincinnati, OH); Jaroslaw Meller (Cincinnati, OH); Cynthia A. Prows (Cincinnati, OH); Tsuyoshi Fukuda (Cincinnati, OH)
C12Q1/6883C12Q1/6806C12Q2600/106C12Q2600/156C12Q2600/172
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Quick Facts
Patent No.
US 12,077,821
App. No.
16/946,399
Granted
Sep 3, 2024
Kind
B2
Abstract

Methods and compositions disclosed herein generally relate to methods of improving clinical and economic outcomes to address adverse effects related to anesthesia, analgesics, opioids, and inadequate pain relief. Embodiments of the invention relate to the association between genes, specific polymorphisms of genes, and non-genetic factors with inadequate pain relief and anesthesia-, analgesic, and/or opioid-related adverse effects. Embodiments of the invention can be used to determine and manage patient risk factors for development of adverse perioperative effects and can allow for personalized anesthesia and pain management for improvement of pain control and reduction of anesthesia-, analgesic-, and opioid-related adverse outcomes. These methods and compositions apply to non-surgical pain management with opioids. Therefore, patients who are genetically predisposed to risk of inadequate pain relief and/or serious side effects from anesthesia, analgesics, and/or opioids can be identified and individualized treatment plans developed for implementation by the clinician to improve clinical and economic outcomes.

Claims (47)

1. A method for treating a human patient for post-operative pain, the method comprising the steps of

a) obtaining a biological sample from a patient in need of treatment for post-operative pain, wherein the biological sample is obtained prior to administering an opioid analgesic to the patient,

b) genotyping the biological sample from the patient to determine the patient's haplotype at four single nucleotide polymorphisms (SNPs) of the organic cation transporter 1 (OCT1) gene identified by rs12208357, rs34130495, rs72552763, and rs34059508, wherein the genotyping is performed using one or more of a PCR-based technique for nucleic acid amplification from the sample, gel electrophoresis, mass spectrometry, and microarray hybridization,

c) assigning an OCT1 haplotype of *1, *2, *3, *4, or *5 based on the patient's genotype at each of the four SNPs as follows

rs12208357

rs34130495

rs72552763

rs34059508

286C > T

1306G > A

1365GAT > del

1498G > C

*1

Arg

Gly

Met

Gly

*2

Arg

Gly

del

Gly

*3

Cys

Gly

Met

Gly

*4

Arg

Ser

Met

Gly

*5

Arg

Gly

del

Arg

assigning the patient to Group 0, 1, or 2 based on the patient's haplotype as follows:

Group 0: *1/*1

Group 1: *1/*2, *1/*3, *1/*4, or *1/*5

Group 2: *2/*2, *2/*3, *2/*4, *2/*5, *3/*3, *3/*4, *3/*5, *4/*4, *4/*5, or *5/*5, and

d) administering fentanyl, hydromorphone, codeine, oxycodone, hydrocodone, tramadol, ondansetron, dexamethasone, methadone, alfentanil, remifentanil, acetaminophen, a non-steroidal anti-inflammatory drug (NSAID), dexmedetomidine, or clonidine, to the patient assigned to Group 2 in step c), or

e) administering morphine to the patient assigned to Group 0 or 1 in step c).

2. The method of claim 1 , wherein the patient is a pediatric patient.

3. The method of claim 1 , further comprising receiving at least one non-genetic risk factor selected from the patient's race, sex, and obstructive sleep apnea disease status.

4. The method of claim 3 , wherein the non-genetic risk factor is race and the race is selected from Caucasian and African American.

5. The method of claim 4 , wherein the race is Caucasian.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 18, 2021
From: SADHASIVAM, SENTHILKUMAR; CHIDAMBARAN, VIDYA; MCAULIFFE, JOHN; ZHANG, KEJIAN; MELLER, JAROSLAW; PROWS, CYNTHIA A.; FUKUDA, TSUYOSHI
To: CHILDREN'S HOSPITAL MEDICAL CENTER
Reel/Frame 055641/0004 →
Continuity (6)
Continuation 16850537 · Apr 16, 2020
Continuation 15915581 · Mar 8, 2018
Continuation 14361946
Provisional Application 61661073 · Jun 18, 2012
Provisional Application 61565400 · Nov 30, 2011
Related Publication 20200318194A1 · Oct 8, 2020