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Sponsors and Collaborators: |
University of Saskatchewan Saskatoon Health Region |
Information provided by: | University of Saskatchewan |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
Post-Vaginal Delivery Perineal Pain |
Drug: Naproxen |
Phase IV |
ChemIDplus related topics: | Naproxen sodium Naproxen |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial |
Estimated Enrollment: | 60 |
Study Start Date: | September 2006 |
Study Completion Date: | May 2007 |
Arms | Assigned Interventions |
1: Experimental
A Naproxen PO + placebo PR
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Drug: Naproxen
Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
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2: Experimental
B Placebo PO + Naproxen PR
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Drug: Naproxen
Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Potential volunteers who meet all of the following criteria are eligible for this study:
Exclusion Criteria:
Potential volunteers meeting one of more of the following criteria may not be enrolled:
Medical conditions including:
Obstetrical conditions including:
Canada, Saskatchewan | |||||
Department of Anesthesia, Royal University Hospital, University of Saskatchewan | |||||
Saskatoon, Saskatchewan, Canada, S7N 0W8 |
University of Saskatchewan |
Saskatoon Health Region |
Principal Investigator: | David C Campbell, MD,MSC,FRCPC | University of Saskatchewan |
Study ID Numbers: | Bio-REB 05-96 |
First Received: | September 19, 2005 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00222976 |
Health Authority: | Canada: Health Canada |
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