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Trial Assessing Maternal Post-Partum Pain (CRAMPS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT01271855
First received: January 5, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

Hypothesis:

The routine use of belladonna/opium (B&O) suppositories will improve patient's self-reported pain control in the first 24-hours after delivery.

Commonly employed methods of controlling post-partum pain include opioid analgesics, non-steroidal anti-inflammatories, acetomenophen, and topical analgesics. Pain medication is generally administered via oral or IV route. Several studies have investigated suppositories as an alternative method of improving pain following delivery.

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 post-partum pain. This quality may significantly improve pain from uterine contractions during the post-partum period.


Condition Intervention Phase
Pain
 Drug: B&O suppository
Other: Control Group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Pain level twenty four hours after delivery [ Time Frame: Twenty four hours ] [ Designated as safety issue: No ]
    The primary outcome will be pain as measured for 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 8, 16, and 24 hours after delivery. This score will be recorded by the patients' nurse at time of administration of next dose.


Secondary Outcome Measures:
  • Additional pain medication [ Time Frame: twenty four hours ] [ Designated as safety issue: No ]
    The number of additional medication administrations beyond B&O suppositories will be recorded.

  • Patient Satisfaction [ Time Frame: Twenty four hours after surgery ] [ Designated as safety issue: No ]
    Patient satisfaction with pain control during hospital stay based on survey completed at discharge.

  • Side effects [ Time Frame: Twenty four hours after delivery ] [ Designated as safety issue: Yes ]
    Frequency of side effects, (including drowsiness, dry mouth, urinary retention, photophobia, rapid pulse, dizziness, blurred vision, constipation, nausea, vomiting, pruritis and urticaria) based on survey to be completed at time of discharge


Enrollment: 217
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
Study participants randomly assigned to the control group will receive routine post-partum pain management per physician preference. Typical post-partum prescriptions for pain at our institutions generally include Norco or Tylenol # 3 and Motrin as needed. Intraveneous Toradol is often given to patients for 24 hours following cesarean deliveries. Post-partum pain medications sometimes include oral Tramadol as well as Epifoam and Dermaplast topical anesthetics. In addition, patients will be given a vegetable oil suppository (placebo) per rectum immediately after delivery, then scheduled every 8-hours for the first 24 hours.
 Other: Control Group
A vegetable oil suppository (placebo) per rectum immediately after delivery, then scheduled every 8-hours for the first 24 hours.
Active Comparator: B&O Suppository group
Study participants randomly assigned to the intervention group will be given a B&O suppository 16.2mg/30mg per rectum immediately after delivery, then every 8 hours for 24 hours following delivery in addition to routine post-partum pain management per physician preference.
 Drug: B&O suppository
B&O suppository 16.2mg/30mg per rectum immediately after delivery, then every 8 hours for 24 hours following delivery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  • Inability to read and understand English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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. Loyola University
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT01271855     History of Changes
Other Study ID Numbers: 201720
Study First Received: January 5, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013