Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539741
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Variability in Analgesic Response to Ibuprofen
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mechanisms of Variability in the Analgesic Response to Ibuprofen Following Third Molar Extraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nonsteroidal anti-inflammatory drugs NSAIDs like ibuprofen are recommended as first-line treatment for post-surgical dental pain However there is variability in analgesic response and some patients require supplemental opioids for adequate pain relief The goal of this study is to identify the factors that contribute to the need for opioid after third molar extraction to help limit unnecessary opioid prescriptions in patients who will have good pain relief with ibuprofen alone
Detailed Description:
The dramatic increase in opioid prescriptions over the past years has been linked to the concomitant rise in opioid addiction and to deaths from opioid abuse Young adults initial exposure to opioid analgesics is often following extraction of their impacted third molars with an average of 5000000 cases in the USA per year Over-prescribing of opioids for surgical pain often 2-5 times more than patients actually use further exacerbates this problem as patients tend to save leftover pills rather than discard them Up to 70 of individuals who become addicted to prescription opioids had access to leftover pills prescribed for others This is particularly troubling as the odds of transitioning to heroin from prescription opioid abuse are much higher than other suspected gateway drugs about 40 fold greater than non-gateway drug users
Multiple studies have demonstrated that non-addicting nonsteroidal anti-inflammatory drugs NSAIDs such as ibuprofen and diclofenac are effective in relieving pain after dental impaction surgery being at least equally efficacious as optimal doses of immediate release opioid formulations combined with acetaminophen However these assessments of pain relief represent average scores and approximately 22 and 50 of individuals required additional opioid-containing rescue analgesics when ibuprofen and diclofenac were employed at FDA-approved dosages A deeper understanding of the sources of variability in pain relief should allow improvements in the overall efficacy of NSAIDs by targeting treatment to those who are most likely to receive sufficient pain relief Thus optimizing pain therapy with NSAIDs by personalization would be expected to help limit the unnecessary prescription of highly addicting immediate release opioids Moreover these results may have applicability to other types of pain that are driven by inflammation
Multiple studies have demonstrated that non-addicting nonsteroidal anti-inflammatory drugs NSAIDs such as ibuprofen and diclofenac are effective in relieving pain after dental impaction surgery being at least equally efficacious as optimal doses of immediate release opioid formulations combined with acetaminophen However these assessments of pain relief represent average scores and approximately 22 and 50 of individuals required additional opioid-containing rescue analgesics when ibuprofen and diclofenac were employed at FDA-approved dosages A deeper understanding of the sources of variability in pain relief should allow improvements in the overall efficacy of NSAIDs by targeting treatment to those who are most likely to receive sufficient pain relief Thus optimizing pain therapy with NSAIDs by personalization would be expected to help limit the unnecessary prescription of highly addicting immediate release opioids Moreover these results may have applicability to other types of pain that are driven by inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None