NCT01271855

Assessing Maternal Post-partum Pain With Suppositories

Official Title:

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

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.

Eligibility

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.

Disease(s) and\or Condition(s)

Pain

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Belladonna and opioid suppository
    • Description: Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
    • Arm Group Labels: Belladonna and opioid suppository
    • Type: DRUG
    • Name: Glycerin Suppository
    • Description: A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
    • Arm Group Labels: Glycerin suppository
Sponsor
  • Loyola University