Tonsillectomy Clinical Trial
Official title:
Home Care Management of Pediatric Pain
The purpose of this study is to determine whether around-the-clock dosing of pain medication, with or without nurse coaching, increases the effectiveness of pain management (i.e., decreased pain intensity scores with and without swallowing, increased use of pain medication, improved sleep, increased oral intake of fluids, decreased negative behaviors, and the same degree of side effects), over time, compared to standard care with "as needed" dosing.
The undertreatment of postoperative pain in children remains a critical problem. Only
recently have clinical trials begun to evaluate the efficacy of pharmacologic interventions
in the management of postoperative pain beyond the immediate postoperative recovery period
and after discharge home following tonsillectomy. Given the fact that approximately 50% of
pediatric surgeries are done on an outpatient basis, this study has the potential to improve
the home pain management of thousands of children. This study is one of the first to
evaluate in a systematic fashion the use of an around-the-clock dosing of a weight
appropriate dose of a nonopioid/opioid combination analgesic compared to as needed dosing.
Because the study will evaluate the effectiveness of both a behavioral intervention and two
different pharmacologic interventions, it will provide important information that should
have a direct clinical application in the management of children's pain.
The consent form is written according to the standards outlined by the Committee on Human
Research, including: 1) an explanation of the purposes of the research and the expected
duration of the subject's participation; 2) a description of the procedures to be followed;
3) a description of any foreseeable risks or benefits to the subject, and any alternative
courses of treatment; 4) a statement describing the extent to which confidentiality of
records will be maintained; 5) a statement whether compensation will be provided and medical
treatment made available if injury occurs; 6) the name and number of the Chair of the
Committee on Human Research; 7) a statement that participation is voluntary, and that the
subject may discontinue participation at any time; and 8) a statement indicating that the
subject has received a copy of the consent document and related materials. A separate form
is signed to authorize access to their health care information.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03266094 -
A Study of BiZactâ„¢ on Children and Adolescents Undergoing Tonsillectomy
|
N/A | |
Completed |
NCT02228135 -
The Effect of Dexamethasone Dosing on Post-tonsillectomy Hemorrhage
|
N/A | |
Completed |
NCT00662987 -
Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy
|
N/A | |
Completed |
NCT00273754 -
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
|
Phase 2 | |
Recruiting |
NCT06122948 -
Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events
|
Phase 3 | |
Recruiting |
NCT03783182 -
Betamethasone (Betapred®) as Premedication for Reducing Postoperative Vomiting and Pain After Tonsillectomy
|
Phase 4 | |
Completed |
NCT03793816 -
Tonsillectomy Using BiZactâ„¢ - a Randomized Side-controlled Clinical Trial
|
N/A | |
Not yet recruiting |
NCT06359925 -
Suprazygomatic Nerve Block in Tonsillectomy Patients
|
N/A | |
Recruiting |
NCT06079125 -
PFDD Versus PFDRT in Chiari Decompression Surgery
|
N/A | |
Recruiting |
NCT01904461 -
HemORL: Monocentric, Prospective, Comparative Study on the Use of a Haemostatic Vacuum Device During Tonsillectomy in Children
|
N/A | |
Not yet recruiting |
NCT00756873 -
Etoricoxib in Ear Nose Throat Surgery
|
Phase 3 | |
Recruiting |
NCT05600595 -
The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children
|
||
Completed |
NCT02987985 -
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy
|
Phase 3 | |
Completed |
NCT04066829 -
Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
|
N/A | |
Recruiting |
NCT05158348 -
A Comparative Study to Measure the Effect of Nebulized Dexmedetomidine
|
Phase 3 | |
Completed |
NCT01605903 -
Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy
|
Phase 2 | |
Enrolling by invitation |
NCT02444533 -
EXPAREL® for Pain After Tonsillectomy
|
Phase 4 | |
Recruiting |
NCT02829515 -
Tonsil Surgery in Sweden: A National Quality Register
|
||
Not yet recruiting |
NCT03491085 -
Role of Antibiotics Post Tonsillectomy
|
Phase 1/Phase 2 | |
Recruiting |
NCT05270109 -
Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity
|
N/A |