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

January 5, 2011
April 25, 2013
May 2009
September 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01271855 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Trial Assessing Maternal Post-Partum Pain
CRAMPS Trial: Controlled Randomized Trial Assessing Maternal Post-partum Pain With Suppositories

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: B&O suppository
    B&O suppository 16.2mg/30mg per rectum immediately after delivery, then every 8 hours for 24 hours following delivery
  • Other: Control Group
    A vegetable oil suppository (placebo) per rectum immediately after delivery, then scheduled every 8-hours for the first 24 hours.
  • 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.
    Intervention: Other: Control Group
  • 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.
    Intervention: Drug: B&O suppository
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
217
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01271855
201720
No
Loyola University
Loyola University
Not Provided
Principal Investigator: Kimberly Kenton, M.D. Loyola University
Loyola University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP