Non-opioids for Analgesia After Adenotonsillectomy in Children
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 3 - 17 |
| Updated: | 11/21/2018 |
| Start Date: | October 25, 2018 |
| End Date: | October 2019 |
| Contact: | Jennifer McCoy, MA |
| Email: | nelsonjl2@upmc.edu |
| Phone: | 4126929879 |
Randomized Clinical Trial of Non-Opioid Pain Medications After Adenotonsillectomy
The goal of this study is to determine if non-opioid pain control is a safe way to manage
pain after adenotonsillectomy surgery in children. The investigators will be randomly
assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain
medication only, and the other group will receive opioid and non-opioid medications for pain
control. The investigators will analyze the data and determine if there is a difference in
pain control between the two drug regimens, and if there are any other associated
complications between the two groups.
This study is important because if we can demonstrate that there is little difference in
outcomes and pain control between the two groups, a strong argument can be made for reducing
or eliminating opioid prescription after adenotonsillectomy. This may protect future children
from the risks of taking opioid medications and help to reduce the scope of the opioid
epidemic.
pain after adenotonsillectomy surgery in children. The investigators will be randomly
assigning children aged 3-17 to one of two groups: one group will receive non-opioid pain
medication only, and the other group will receive opioid and non-opioid medications for pain
control. The investigators will analyze the data and determine if there is a difference in
pain control between the two drug regimens, and if there are any other associated
complications between the two groups.
This study is important because if we can demonstrate that there is little difference in
outcomes and pain control between the two groups, a strong argument can be made for reducing
or eliminating opioid prescription after adenotonsillectomy. This may protect future children
from the risks of taking opioid medications and help to reduce the scope of the opioid
epidemic.
Purpose: To determine if non-opioid pain control is a safe and effective option in the
treatment of post-operative pain following adenotonsillectomy in various pediatric age
groups.
Methods: The subject population will be patients between the ages of 3 and 17 who will
undergo adenotonsillectomy. The study will consist of two unblinded arms - patients receiving
standard pain control regimen which include opioids and non-opioids, and patients receiving
non-opioid pain medications only. In the diary they will receive, patients or caregivers will
record quantity and dosage of pain medication taken each day, a survey, and pain ratings
measured by the Wong-Baker FACES Pain Rating Scale. Within 4-8 weeks post-operatively the
patients will return for a follow up appointment along with their diary. Demographic
information such as age, race, gender, household income will be extracted from the diary and
the electronic medical record. Information such as surgical technique, concurrent operations,
post-operative pain prescription (types, weight based dosage, and total days prescribed) will
be extracted from the electronic medical record and recorded as well. Outcomes measured will
include pain scale rating and rates of complications between the two groups.
Significance: If it can be demonstrated that non-opioid pain control after adenotonsillectomy
does not lead to increased pain or worse outcomes in certain pediatric age groups, a strong
argument can be made for the cessation of opioid prescription for these ages following
adenotonsillectomy. Given the widespread opioid epidemic, this would be a significant step in
curbing the massive opioid problem, as well as reducing the adverse effects of opioid usage
in pediatric populations.
treatment of post-operative pain following adenotonsillectomy in various pediatric age
groups.
Methods: The subject population will be patients between the ages of 3 and 17 who will
undergo adenotonsillectomy. The study will consist of two unblinded arms - patients receiving
standard pain control regimen which include opioids and non-opioids, and patients receiving
non-opioid pain medications only. In the diary they will receive, patients or caregivers will
record quantity and dosage of pain medication taken each day, a survey, and pain ratings
measured by the Wong-Baker FACES Pain Rating Scale. Within 4-8 weeks post-operatively the
patients will return for a follow up appointment along with their diary. Demographic
information such as age, race, gender, household income will be extracted from the diary and
the electronic medical record. Information such as surgical technique, concurrent operations,
post-operative pain prescription (types, weight based dosage, and total days prescribed) will
be extracted from the electronic medical record and recorded as well. Outcomes measured will
include pain scale rating and rates of complications between the two groups.
Significance: If it can be demonstrated that non-opioid pain control after adenotonsillectomy
does not lead to increased pain or worse outcomes in certain pediatric age groups, a strong
argument can be made for the cessation of opioid prescription for these ages following
adenotonsillectomy. Given the widespread opioid epidemic, this would be a significant step in
curbing the massive opioid problem, as well as reducing the adverse effects of opioid usage
in pediatric populations.
Inclusion Criteria:
• Patients age 3 - 17 undergoing adenotonsillectomy
Exclusion Criteria:
- Down syndrome
- History of coagulopathy
- Craniofacial abnormalities
- Caregivers who cannot speak, read, or write in English proficiently
- Patients who take opioids during the enrollment period
- Patients who take chronic opioids
- Pregnancy
- Allergy to or contraindication for taking any of the study medications
- Patients who have the inability to communicate
- Patients who have the inability to localize pain
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