NCT00222976

Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control

Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-Vaginal Delivery Perineal Pain

Interventions

Type	Name	Description
DRUG	Naproxen	Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR

Timeline

• Start date: 2006-09-01
• Completion: 2007-05-01
• First posted: 2005-09-22
• Last updated: 2007-11-15

Locations

1 site across 1 country: Canada