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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00222976
• Date of registration: 19/09/2005
• Prospective Registration: Yes
• Primary sponsor: University of Saskatchewan
• Public title: Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
• Scientific title: Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial
• Date of first enrolment: September 2006
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00222976
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: David C Campbell, MD,MSC,FRCPC
• Affiliation: University of Saskatchewan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Post-Vaginal Delivery Perineal Pain

Intervention(s)

Drug: Naproxen

Primary Outcome(s)

post-vaginal delivery perineal pain scores will be measured using a visual analog scale. [Time Frame: 1 day]

Secondary Outcome(s)

additional requests for analgesia. [Time Frame: until completion of study]

medication adverse effects [Time Frame: until completion of study]

patient preference of route of administration [Time Frame: 1 day]

Secondary ID(s)

Bio-REB 05-96

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Saskatoon Health Region