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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Saskatoon Health Region
• Treatments: Naproxen

Criteria

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