Assessing Maternal Post-partum Pain With Suppositories



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:July 22, 2009
End Date:September 29, 2011

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CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories

This trial will evaluate whether the routine use of belladonna/opium (B&O) suppositories
improve patients' self-reported pain control in the first 24-hours after delivery.

Childbirth is commonly regarded as one of life's most painful experiences and, like
childbirth, the postpartum period can also be painful for women. Pain in the immediate
postpartum period may significantly affect a woman's overall delivery experience. Pain
control is especially important in this period, as women are bonding with their infant and
trying to initiate breastfeeding, which may be adversely affected by poor pain management.

Postpartum pain may come from multiple sources. Women experience uterine cramping as a result
of uterine involution. Depending on delivery type, women may also have incision pain
following cesarean section or perineal pain resulting from episiotomy, perineal tears, or
generalized genital trauma during delivery. Perineal pain is common, present in 75% of
patients with intact perineum and up to 95-97% with perineal lacerations or episiotomies
during the first day after delivery. Commonly employed methods of controlling postpartum pain
include opioid analgesics, non-steroidal anti-inflammatories, acetaminophen, and topical
analgesics. Pain medication is generally administered via oral or intravenous route. Several
studies have investigated suppositories as an alternative method of improving pain following
delivery. A double-blinded randomized controlled trial by Wilasrusmee et al (2008) showed
naproxen suppositories to be effective for reducing perineal pain after vaginal delivery.
Another study showed prophylactic rectal diclofenac to provide effective analgesia after
perineal repair, maintained into second and third day postpartum, and a Cochrane Review
showed NSAID suppositories to be associated with less pain 24 hours after birth.

Rectal analgesia provides a means of improving pain control through local effects on the
perineum and uterus while possibly decreasing systemic absorption, which may in turn decrease
systemic side effects and transmission to the newborn infant through breast milk. B&O
suppositories contain two medications that could potentially decrease postpartum pain.
Morphine, the principle agent in opium, binds opioid receptors and blocks ascending pain
pathways. Atropine, a major active component of belladonna, blocks acetylcholine receptors,
leading to smooth muscle relaxation. This quality may significantly improve pain from uterine
contractions during the postpartum period. The primary aim of our study is to investigate
whether belladonna and opium suppositories decrease patient-reported pain in the immediate
postpartum period.

Inclusion Criteria:

- Anticipated Vaginal or Cesarean delivery at Gottlieb Medical Center or Loyola
University Medical Center

- > 34 weeks gestation at time of delivery

- > 18 years old

- No known allergy to belladonna, opium, or vegetable oil suppositories

- Able to consent and complete study documents

Exclusion Criteria:

- Chronic pain condition or on narcotic medication prior to admission

- Contraindications to B&O suppositories, including patients with glaucoma, severe
hepatic, or renal disease; bronchial asthma; narcotic idiosyncrasies; respiratory
depression; convulsive disorders; acute alcoholism; delirium tremens; history of
hypersensitivity to any component of product.
We found this trial at
2
sites
Melrose Park, Illinois 60160
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Melrose Park, IL
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Maywood, Illinois 60153
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Maywood, IL
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