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

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.

Study Overview

• Status: Completed
• Conditions: Post-Vaginal Delivery Perineal Pain
• Intervention / Treatment: Drug: Naproxen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatoon Health Region
• Investigators: Principal Investigator: David C Campbell, MD,MSC,FRCPC, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: September 19, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): November 15, 2007
• Last Update Submitted That Met QC Criteria: November 13, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: Bio-REB 05-96