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

Condition(s) targeted: Post-Vaginal Delivery Perineal Pain

Intervention: Naproxen (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Saskatchewan

Official(s) and/or principal investigator(s):
David C Campbell, MD,MSC,FRCPC, Principal Investigator, Affiliation: University of Saskatchewan

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.

Official title: Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial

Study design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: post-vaginal delivery perineal pain scores will be measured using a visual analog scale.

Secondary outcome:

patient preference of route of administration

medication adverse effects

additional requests for analgesia.

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.

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

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

Starting date: September 2006
Ending date: May 2007
Last updated: November 13, 2007