Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222976
Status:
COMPLETED
Last Update Posted:
2007-11-15
First Post:
2005-09-19
Brief Title:
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine whether the route of administration of naproxen either by mouth or rectally influences post-vaginal delivery perineal pain control
Detailed Description:
Postpartum perineal pain is common after vaginal delivery Naproxen suppositories have been shown to be effective at reducing postpartum perineal pain To date no studies have investigated the efficacy of oral naproxen for perineal pain control Currently rectal naproxen is used postpartum because of an assumption that there is a local effect compared to oral administration However this effect has never been documented in the literature
Principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective If oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain then current practice would be challenged
The primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control Pain scores will be measured using a visual analog scale The secondary outcome measures are three-fold patient preference of route of administration medication adverse effects and additional requests for analgesia The working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route
Principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective If oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain then current practice would be challenged
The primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control Pain scores will be measured using a visual analog scale The secondary outcome measures are three-fold patient preference of route of administration medication adverse effects and additional requests for analgesia The working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route
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