PainNCT06777875
COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children
An observational study of Pain and Genetic Change, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Genetic Change, Children, Only
- How many people
- 200 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Mar 2025to 13 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- All children 8 years to 18 years
- Undergoing orthopedic, abdominal, thoracic, and plastic surgeries
- American Society of Anesthesiologists classification (ASA) I-II-III
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
Roland Kaddoum
Beirut
Roland Kaddoum, MD, rk16@aub.edu.lb
About this study
Official title: COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children Undergoing Orthopedic, Abdominal, Thoracic, and Plastic Surgeries.
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]:
Read more
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.
Read the detailed description
Inadequately treated pain in children undergoing surgery is a major concern for health providers. Recent evidence indicates that pain sensitivity differs among races and ethnicities and genetic makeup. Catechol-O-methyltransferase (COMT) polymorphisms (rs6269, rs4633, rs4818 and rs4680) which are inherited together in different phenotypes influence clinical presentations and responses to pain.
A118G single-nucleotide polymorphism (SNP) in the mu-opioid receptor1 (OPRM1) gene is associated with differences in pain perception and opioid requirements. The effect of genome variations in the COMT gene and in the OPRM1 on postoperative pain perception and morphine analgesia in children needs further exploration. The main objective of this study was to investigate whether the OPRM1 and COMT SNPs influence postoperative pain scores in children between the ages of 8 and 18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries. Secondary objective includes assessing whether OPRM1 and COMT SNPs influence postoperative sedation score, intraoperative and postoperative opioid requirements, length of stay in the post anesthesia care unit (PACU), and signs of respiratory depression (RD) and postoperative nausea and vomiting (PONV).
Methodology: A prospective cohort genotype-blinded observational study will be conducted. A convenience sample of 200 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). The primary outcome of the study is the post operative pain score in PACU.
Secondary outcomes include the postoperative sedation score, intraoperative and postoperative opioid requirements, length of stay in the PACU, and signs of RD and PONV. To test the hypothesis that COMT and OPRM1 SNPs are associated with postoperative analgesia outcomes in children, SPSS version 29 will be used. Allelic and genotype frequencies will be examined by the Hardy-Weinberg equilibrium (HWE) test. To analyze the association between the different genetic variations and the outcomes, bivariate analysis will be performed. Variables measured over time will be compared between the groups using an exploratory mixed model analysis. Time to first post-operative opioid requirement will be analyzed using the survival analysis Kaplan Meier curve. Such understanding will pave the way for individual tailoring and optimization of pain assessment and management in children undergoing orthopedic, abdominal, thoracic, and plastic surgical procedures.
- Conditions
- Pain, Genetic Change, Children, Only
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain scores measured using the Numerical Rating Scale (NRS) (ranging from 0 to 10, with 0 no pain and 10 worst pain)
Measured: Until discharge from PACU (about 3 hours)
Secondary outcomes (5)
Postoperative sedation
Postoperative sedation measured using the Richmond Agitation Sedation Scale (RASS) (ranging from -5 to +4, with -5 unarousable and +4 combative)
Measured: Until discharge from PACU (about 3 hours)
Use of intraoperative and post-operative opioids
Use of intraoperative and post-operative opioids (Yes/No)
Measured: Until discharge from PACU (about 3 hours)
Length of post-anesthesia care unit (PACU) stay
Length of post-anesthesia care unit (PACU) stay measured in hours
Measured: Until discharge from PACU (about 3 hours)
Postoperative respiratory depression
Postoperative respiratory depression (Yes/No)
Measured: Until discharge from PACU (about 3 hours)
Postoperative nausea and vomiting
Postoperative nausea and vomiting (Yes/No)
Measured: Until discharge from PACU (about 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start10 Mar 2025
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Kaddoum, American University of Beirut Medical Center
- Investigators
- Roland Kaddoum, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777875
- Sponsor's protocol ID
- BIO-2024-0365
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMT and OPRM1 Polymorphisms and Their Effect on Post-Operative Pain in Children Undergoing Orthopedic, Abdominal, Thoracic, and Plastic Surgeries.
- ClinicalTrials.gov ID
- NCT06777875
- Acronym / sponsor ID
- BIO-2024-0365
- Conditions
- Pain, Genetic Change, Children, Only
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inadequately treated pain in children undergoing surgery is a major concern for health providers. Recent evidence indicates that pain sensitivity differs among races and ethnicities and genetic makeup. Catechol-O-methyltransferase (COMT) polymorphisms (rs6269, rs4633, rs4818 and rs4680) which are inherited together in different phenotypes influence clinical presentations and responses to pain.
A118G single-nucleotide polymorphism (SNP) in the mu-opioid receptor1 (OPRM1) gene is associated with differences in pain perception and opioid requirements. The effect of genome variations in the COMT gene and in the OPRM1 on postoperative pain perception and morphine analgesia in children needs further exploration. The main objective of this study was to investigate whether the OPRM1 and COMT SNPs influence postoperative pain scores in children between the ages of 8 and 18 undergoing orthopedic, abdominal, thoracic, and plastic surgeries. Secondary objective includes assessing whether OPRM1 and COMT SNPs influence postoperative sedation score, intraoperative and postoperative opioid requirements, length of stay in the post anesthesia care unit (PACU), and signs of respiratory depression (RD) and postoperative nausea and vomiting (PONV).
Methodology: A prospective cohort genotype-blinded observational study will be conducted. A convenience sample of 200 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). The primary outcome of the study is the post operative pain score in PACU.
Secondary outcomes include the postoperative sedation score, intraoperative and postoperative opioid requirements, length of stay in the PACU, and signs of RD and PONV. To test the hypothesis that COMT and OPRM1 SNPs are associated with postoperative analgesia outcomes in children, SPSS version 29 will be used. Allelic and genotype frequencies will be examined by the Hardy-Weinberg equilibrium (HWE) test. To analyze the association between the different genetic variations and the outcomes, bivariate analysis will be performed. Variables measured over time will be compared between the groups using an exploratory mixed model analysis. Time to first post-operative opioid requirement will be analyzed using the survival analysis Kaplan Meier curve. Such understanding will pave the way for individual tailoring and optimization of pain assessment and management in children undergoing orthopedic, abdominal, thoracic, and plastic surgical procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (3 listed)
- All children 8 years to 18 years
- Undergoing orthopedic, abdominal, thoracic, and plastic surgeries
- American Society of Anesthesiologists classification (ASA) I-II-III
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain scores
Time frame: Until discharge from PACU (about 3 hours)
Pain scores measured using the Numerical Rating Scale (NRS) (ranging from 0 to 10, with 0 no pain and 10 worst pain)
5 secondary outcomes
Postoperative sedation
Time frame: Until discharge from PACU (about 3 hours)
Use of intraoperative and post-operative opioids
Time frame: Until discharge from PACU (about 3 hours)
Length of post-anesthesia care unit (PACU) stay
Time frame: Until discharge from PACU (about 3 hours)
Postoperative respiratory depression
Time frame: Until discharge from PACU (about 3 hours)
Postoperative nausea and vomiting
Time frame: Until discharge from PACU (about 3 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland Kaddoum, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Genetic Change, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland Kaddoum, MD (01350000 ext. 6380, rk16@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: Until discharge from PACU (about 3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.