Department of Anesthesia, Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
NCT Number: NCT00222976
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.
Looking for future studies?
Notify Me18 year–40 year
Female
Interventional
Phase 4
Saskatoon, Saskatchewan, S7N 0W8, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
Time frame: 1 day
Time frame: 1 day
Time frame: until completion of study
Time frame: until completion of study
University of Saskatchewan
Other
Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.