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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Vaginal Delivery Perineal Pain

Intervention / Treatment
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* Drug: Naproxen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential volunteers who meet all of the following criteria are eligible for this study: Active labor, whether spontaneous or induced Age between 18 and 40 years old Nulliparous BMI < 40 Single live intrauterine fetus in cephalic presentation Term gestation (370 weeks to 416 weeks inclusive) as defined by ultrasound or last menstrual period dating Intrapartum epidural labour analgesia Written informed consent Exclusion Criteria: Potential volunteers meeting one of more of the following criteria may not be enrolled: Medical conditions including: Naproxen, aspirin or other non-steroidal anti-inflammatory drug hypersensitivity Asthma Peptic ulcer disease or other inflammatory gastrointestinal disease Renal, hepatic or cardiac disease Coagulopathy Rectal or anal pathology including recent (within 1 month) rectal bleeding Prescribed medications including lithium, furosemide, antihypertensives, anticoagulants, aminoglycosides, hydantoins, or sulfonamides Obstetrical conditions including: Multiple pregnancy Extensive perineal trauma (third or fourth degree laceration) Forceps delivery Cesarean section delivery Paracervical or pudendal nerve blocks Vulval or vaginal hematomas Nulliparous women not requiring intrapartum epidural labour analgesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>A Naproxen PO + placebo PR | Drug: Naproxen<br>* Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR<br>|
| Experimental: 2<br>B Placebo PO + Naproxen PR | Drug: Naproxen<br>* Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-vaginal delivery perineal pain scores will be measured using a visual analog scale. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient preference of route of administration |  | 1 day | 
| medication adverse effects |  | until completion of study | 
| additional requests for analgesia. |  | until completion of study |