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

Sponsor:	University of Saskatchewan
Collaborator:	Saskatoon Health Region
Information provided by:	University of Saskatchewan
ClinicalTrials.gov Identifier:	NCT00222976

Purpose

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.

Condition	Intervention	Phase
Post-Vaginal Delivery Perineal Pain	Drug: Naproxen	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:

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

Secondary Outcome Measures:

patient preference of route of administration [ Time Frame: 1 day ]
medication adverse effects [ Time Frame: until completion of study ]
additional requests for analgesia. [ Time Frame: until completion of study ]

Estimated Enrollment:	60
Study Start Date:	September 2006
Study Completion Date:	May 2007

Arms	Assigned Interventions
Experimental: 1 A Naproxen PO + placebo PR	Drug: Naproxen Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
Experimental: 2 B Placebo PO + Naproxen PR	Drug: Naproxen Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222976

Locations

Canada, Saskatchewan
Department of Anesthesia, Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8

Sponsors and Collaborators

University of Saskatchewan

Saskatoon Health Region

Investigators

Principal Investigator:

David C Campbell, MD,MSC,FRCPC

University of Saskatchewan

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00222976 History of Changes
Other Study ID Numbers:	Bio-REB 05-96
Study First Received:	September 19, 2005
Last Updated:	November 13, 2007
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012