Status:
COMPLETED
Pharmacogenomics Analysis of Morphine Pharmacokinetics in Pediatric Tonsillectomy and Adenoidectomy
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Children's Anesthesiology Associates, Ltd.
Conditions:
Tonsillectomy
Adenoidectomy
Eligibility:
All Genders
4-18 years
Brief Summary
Intravenous (IV) morphine requirement for immediate postoperative pain control depends upon the complex interplay of patient history, wound severity, environment, and genetics. Even for relatively uni...
Detailed Description
Morphine Tonsilectomy and Adenoidectomy (T\&A) Pharmacokinetics (PK) study will be done as a part of the larger institutional Center for Applied Genomics (CAG) project entitled "A Study of the Genetic...
Eligibility Criteria
Inclusion
- Concurrent enrollment in the GCPD study (IRB 2006-7-4886)
- Scheduled for day surgery T\&A with expected same day discharge at CHOP Main in Philadelphia, Pennsylvania (PA) or the CHOP Ambulatory Surgical Facilities (ASFs) in Chalfont, PA; Exton, PA; or Voorhees, New Jersey (NJ)
- Male or female, age 4 - 18 years, all races and ethnic backgrounds
- Able to self-report pain on the Faces Pain Scale - Revised (FPS-R).
- Informed consent as addendum to GCPD consent document
- Assent for children ≥7 years of age
Exclusion
- Parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
- Non-English speaking subjects or parents. The reliability of the morphine analgesic requirement phenotype could be adversely affected by subtle communication differences between subjects and nursing staff assessing pain and administering morphine during patient recovery should language barriers exist. Parents must also be fluent in English as they will be at the bedside shortly after their child's arrival in recovery and could influence how their child understands pain scoring and how they interact with the nursing and research staff.
- Those parents/guardian or subjects not consenting to, or willing to participate in the GCPD study (IRB 2006-7-4886).
- Patients \< 4 y of age were excluded to improve phenotype reliability. Due to a higher empirical risk of postoperative obstruction following T\&A, children \< 4 years of age are admitted for overnight observation. The titration of morphine is more difficult in these patients as clinicians generally follow more restrictive dosing regimens and the total morphine dose is drawn out over an extended period. Furthermore, the self-report Faces Pain Scale - Revised (FPS-R) has been validated for children ≥ 4 y and will be used to corroborate the morphine response phenotypes that are primarily based on morphine doses administered to achieve low Face, Legs, Activity, Cry, Consolability (FLACC) scores. The latter behavioral scoring is required for early morphine administration as children and adolescents emerging from anesthesia may have difficulty expressing themselves in the first 30 min. In addition, it is important for the study statistical analysis to have a sequential scoring system over time that is applicable to all ages. Finally, the incidence of emergence agitation/delirium, a clinical phenomenon that shares some features of pain, but becomes distinct over 15-30 minutes, is higher in younger patients. (Sikich, 2004; Vlajkovic, 2007) By excluding children \< 4 years Investigators decrease the proportion of subjects whose FLACC scores may be high on the basis of emergence agitation/delirium.
- Significant comorbid conditions requiring a non-standard anesthetic regimen such as a history of severe post-operative nausea and vomiting requiring propofol infusion, a total intravenous anesthestic (TIVA) technique and/or mandating planned post-operative hospital admission.
- Documented allergy or adverse reaction to morphine in the patient.
- Use of opioids (e.g. codeine, oxycodone, morphine, hydromorphone) within the previous month.
- Use of non-steroidal anti-inflammatory agents or acetaminophen in the 3 days preceding the T\&A. No acetaminophen will be included in the premedication regimen on the day of surgery.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
878 Patients enrolled
Trial Details
Trial ID
NCT00836264
Start Date
January 1 2009
End Date
November 1 2011
Last Update
April 2 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104