COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children

NCT06777875 | Recruiting

• 1 other identifier: BIO-2024-0365
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate whether the A118G single-nucleotide polymorphism (SNP) in the mu-opioid receptor1(OPRM1) and Catechol-O-methyltransferase (COMT) SNPs influence postoperative pain scores in children between the ages of 8 and 18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries. The main question\[s\] it aims to answer \[is\]: Do OPRM1 and COMT SNPs influence postoperative pain scores in children between the ages of 8 and 18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries? Participants will be assessed for their pain scores, sedation level, the amount of postoperative analgesics received, duration of their stay in the post-anesthesia care unit, and toxicity.

Conditions

Pain; Genetic Change; Children, Only

Outcome Measures

Primary Outcomes (1)

• Pain scores

  Pain scores measured using the Numerical Rating Scale (NRS) (ranging from 0 to 10, with 0 no pain and 10 worst pain)

  Until discharge from PACU (about 3 hours)

Secondary Outcomes (5)

• Postoperative sedation

  Until discharge from PACU (about 3 hours)

• Use of intraoperative and post-operative opioids

  Until discharge from PACU (about 3 hours)

• Length of post-anesthesia care unit (PACU) stay

  Until discharge from PACU (about 3 hours)

• Postoperative respiratory depression

  Until discharge from PACU (about 3 hours)

• Postoperative nausea and vomiting

  Until discharge from PACU (about 3 hours)

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children between the ages of 8-18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries will be recruited from the American University of Beirut Medical Center (AUBMC).

You may qualify if:

• All children 8 years to 18 years
• Undergoing orthopedic, abdominal, thoracic, and plastic surgeries
• American Society of Anesthesiologists classification (ASA) I-II-III

You may not qualify if:

• Children with schizoid personality disorders, phobias, and anxiety
• Patients with neuropathic pain associated with surgeries requiring surgical treatment.
• Children presented with all types of depressive disorders, atypical bipolar disorder, or a suspicion of substance abuse.
• American Society of Anesthesiologists classification (ASA) ≥IV
• All patients receiving regional anesthesia, local blocks, epidural and caudal blocks.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

Roland Kaddoum

Beirut, Lebanon

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous whole blood (2 mL) will be sampled into coded Ethylenediaminetetraacetic acid (EDTA) tubes at the time of study enrollment and stored at -80°C. Samples will be obtained during the insertion of the IV in preparation for anesthesia or as left over from blood withdrawn for complete blood count (CBC) in an EDTA purple tube. Genomic DNA will be purified from each blood using a Qiagen kit according to the manufacturer's instructions. Four Catechol-O-methyltransferase (COMT) single-nucleotide polymorphisms (SNPs) (rs6269, rs4633, rs4818, rs4680 and the rs179971 variant.).

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roland Kaddoum, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Kaddoum, MD

CONTACT

01350000; rk16@aub.edu.lb

Thouraya HajAli

CONTACT

01350000; th64@aub.edu.lb

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 16, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 13, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)