Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2006
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 15, 2007
November 1, 2007
September 19, 2005
November 13, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
post-vaginal delivery perineal pain scores will be measured using a visual analog scale.
1 day
Secondary Outcomes (3)
patient preference of route of administration
1 day
medication adverse effects
until completion of study
additional requests for analgesia.
until completion of study
Study Arms (2)
1
EXPERIMENTALA Naproxen PO + placebo PR
2
EXPERIMENTALB Placebo PO + Naproxen PR
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Saskatchewanlead
- Saskatoon Health Regioncollaborator
Study Sites (1)
Department of Anesthesia, Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David C Campbell, MD,MSC,FRCPC
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 22, 2005
Study Start
September 1, 2006
Study Completion
May 1, 2007
Last Updated
November 15, 2007
Record last verified: 2007-11