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Completed

NCT Number: NCT01271855

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Loyola Univeristy Medical Center, Maywood, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Belladonna and opioid suppository

Drug

Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery

Glycerin Suppository

Drug

A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.

Primary outcomes

  1. Pain Level Twenty Four Hours After Delivery

    Time frame: Twenty-four hours

    The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).

Secondary outcomes

  1. Number of Patients Taking Additional Pain Medications

    Time frame: Twenty-four hours

    Twenty-four hours after delivery, the number of participants taking additional pain medications will be recorded.

  2. Patient Satisfaction

    Time frame: Discharge

    Patients' satisfaction with their pain control is recorded at the time of discharge using a five point scale ranging from 1 (Not Satisfied) to 3 (Okay) to 5 (Very Satisfied).

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

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

Acronym: CRAMPS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2011
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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