Status:
ACTIVE_NOT_RECRUITING
Personalizing Perioperative Analgesia in Children
Lead Sponsor:
Senthil Sadhasivam
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Postoperative Pain
Eligibility:
All Genders
3-15 years
Brief Summary
In the United States alone, each year approximately 5 million children undergo painful surgery, many of them experience serious side-effects with opioids and inadequate pain relief. Safe and effective...
Detailed Description
Measures and Procedures: Participants will receive standard care, standard anesthetic and an intraoperative dose of morphine per the clinical team. Research procedures will include: 1. Blood draws f...
Eligibility Criteria
Inclusion
- boys and girls,
- 3-15 years of age,
- all races,
- American Society of Anesthesiologists (ASA) physical status 1,2, and 3,
- children with history of significant snoring suggestive of obstructive sleep apnea (OSA),
- Scheduled for tonsillectomy (T) or tonsillectomy and adenoidectomy (T and A).
Exclusion
- allergic to study medications
- developmental delay,
- liver and renal diseases,
- preoperative pain requiring analgesics,
- children who have problems with pupil or pupillary reaction due to disease
- preoperative medications influencing pupillary size
- non-English speaking participants and families
- Body Mass Index ≥30
- Participants undergoing additional procedures during surgery
- Children with certain cardiac conditions
- Children with severe lung disease
- Children with a history of seizures currently treated on medication
- Children with psychiatric/psychological conditions for which patient currently takes medication
Key Trial Info
Start Date :
February 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 25 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01140724
Start Date
February 7 2022
End Date
December 25 2025
Last Update
April 15 2025
Active Locations (1)
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1
UPMC Children's Hospital
Pittsburgh, Pennsylvania, United States, 15224