COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorAmerican University of Beirut Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All children 8 years to 18 years
Undergoing orthopedic, abdominal, thoracic, and plastic surgeries
American Society of Anesthesiologists classification (ASA) I-II-III
Disqualifiers
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
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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)
Time frame
Until discharge from PACU (about 3 hours)Secondary outcomes
1
Postoperative sedation
Postoperative sedation measured using the Richmond Agitation Sedation Scale (RASS) (ranging from -5 to +4, with -5 unarousable and +4 combative)
Time frame
Until discharge from PACU (about 3 hours)2
Use of intraoperative and post-operative opioids
Use of intraoperative and post-operative opioids (Yes/No)
Time frame
Until discharge from PACU (about 3 hours)3
Length of post-anesthesia care unit (PACU) stay
Length of post-anesthesia care unit (PACU) stay measured in hours
Time frame
Until discharge from PACU (about 3 hours)4
Postoperative respiratory depression
Postoperative respiratory depression (Yes/No)
Time frame
Until discharge from PACU (about 3 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov