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| Name | Class |
|---|---|
| Saskatoon Health Region | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | A Naproxen PO + placebo PR |
|
| 2 | Experimental | B Placebo PO + Naproxen PR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR |
|
| Measure | Description | Time Frame |
|---|---|---|
| post-vaginal delivery perineal pain scores will be measured using a visual analog scale. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| patient preference of route of administration | 1 day | |
| medication adverse effects | until completion of study | |
| additional requests for analgesia. |
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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:
Nulliparous women not requiring intrapartum epidural labour analgesia
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| Name | Affiliation | Role |
|---|---|---|
| David C Campbell, MD,MSC,FRCPC | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesia, Royal University Hospital, University of Saskatchewan | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| until completion of study |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |