Hydromorphone vs Fentanyl in Children Undergoing Tonsillectomy Surgery
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
A RCT to compare hydromorphone versus fentanyl for pain control following tonsillectomy or adenotonsillectomy surgery.
Full description
This is a randomized clinical trial with masked assessment, comparing recovery indices for patients receiving intermediate acting versus short acting opioid analgesia using hydromorphone or fentanyl as intraoperative analgesics. An otherwise standardized anesthetic and analgesic regimen will be utilized, consistent with routine care at SLCH. Patients will be randomized 1:1 in block sizes of 5 per group. Patients will be randomized to receive either hydromorphone or fentanyl throughout the perioperative period by opening a sealed protocol envelope.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Children ages 2 to 15 years old
- Presenting for tonsillectomy or adenotonsillectomy surgery
- American Society of Anesthesiologists Physical Status (ASAPS) Classification 1, 2 or 3
- Provide Informed Consent / Assent (as appropriate)
Exclusion criteria
- Additional Concurrent surgeries, exclusive of myringotomy tubes, minor oral/nasal procedures (e.g. frenulectomy), and endoscopic procedures
- Revision tonsillectomy or revision adenotonsillectomy surgery
- Known pregnancy
- Any condition which would make the participant, in the opinion of the investigator or the attending anesthesiologist caring for the patient, unsuitable for the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
189 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal