NCT01271855

Assessing Maternal Post-partum Pain With Suppositories

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Loyola University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Belladonna and opioid suppository	Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
DRUG	Glycerin Suppository	A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.

Timeline

• Start date: 2009-07-22
• Primary completion: 2011-09-29
• Completion: 2011-09-29
• First posted: 2011-01-07
• Last updated: 2018-03-07
• Results posted: 2018-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study