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

NCT ID: NCT00222976

Last Updated: 2007-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-05-31

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.

Conditions

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Post-Vaginal Delivery Perineal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

A Naproxen PO + placebo PR

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR

2

B Placebo PO + Naproxen PR

Group Type EXPERIMENTAL

Naproxen

Intervention Type DRUG

Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR

Interventions

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Naproxen

Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Potential volunteers who meet all of the following criteria are eligible for this study:

1. Active labor, whether spontaneous or induced
2. Age between 18 and 40 years old
3. Nulliparous
4. BMI \< 40
5. Single live intrauterine fetus in cephalic presentation
6. Term gestation (370 weeks to 416 weeks inclusive) as defined by ultrasound or last menstrual period dating
7. Intrapartum epidural labour analgesia
8. Written informed consent

Exclusion Criteria

* Potential volunteers meeting one of more of the following criteria may not be enrolled:

1. Medical conditions including:

1. Naproxen, aspirin or other non-steroidal anti-inflammatory drug hypersensitivity
2. Asthma
3. Peptic ulcer disease or other inflammatory gastrointestinal disease
4. Renal, hepatic or cardiac disease
5. Coagulopathy
6. Rectal or anal pathology including recent (within 1 month) rectal bleeding
7. Prescribed medications including lithium, furosemide, antihypertensives, anticoagulants, aminoglycosides, hydantoins, or sulfonamides
2. Obstetrical conditions including:

1. Multiple pregnancy
2. Extensive perineal trauma (third or fourth degree laceration)
3. Forceps delivery
4. Cesarean section delivery
5. Paracervical or pudendal nerve blocks
6. Vulval or vaginal hematomas
3. Nulliparous women not requiring intrapartum epidural labour analgesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saskatoon Health Region

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Principal Investigators

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David C Campbell, MD,MSC,FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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Department of Anesthesia, Royal University Hospital, University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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Bio-REB 05-96

Identifier Type: -

Identifier Source: org_study_id