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Assessing Maternal Post-partum Pain With Suppositories (CRAMPS)

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ClinicalTrials.gov Identifier: NCT01271855
Recruitment Status : Completed
First Posted : January 7, 2011
Results First Posted : February 6, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Loyola University

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Belladonna and opioid suppository Drug: Glycerin Suppository Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to receive either a belladonna and opioid suppository or a glycerin suppository (placebo) every eight hours after delivery during the first 24 hours after delivery using a 1:1 allocation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories
Actual Study Start Date : July 22, 2009
Actual Primary Completion Date : September 29, 2011
Actual Study Completion Date : September 29, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Glycerin suppository
Women assigned to this arm receive a glycerin suppository (placebo) every 8 hours after delivery during the first 24 hours postpartum
Drug: Glycerin Suppository
A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.

Experimental: Belladonna and opioid suppository
Women assigned to this arm receive a belladonna and opioid (B&O) suppository every 8 hours after delivery during the first 24 hours postpartum
Drug: Belladonna and opioid suppository
Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271855


Locations
United States, Illinois
Loyola Univeristy Medical Center
Maywood, Illinois, United States, 60153
Gottlieb Memorial Hospital
Melrose Park, Illinois, United States, 60160
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Kimberly Kenton, M.D. Northwestern University

Publications:
Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01271855     History of Changes
Other Study ID Numbers: 201720
First Posted: January 7, 2011    Key Record Dates
Results First Posted: February 6, 2018
Last Update Posted: March 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Loyola University:
Belladonna
Opium
Suppository

Additional relevant MeSH terms:
Analgesics, Opioid
Glycerol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cryoprotective Agents
Protective Agents