Phase 4
Completed N=100
Assessing Maternal Post-partum Pain With Suppositories
Source: ClinicalTrials.gov NCT01271855 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Pain Level Twenty Four Hours After Delivery — 1; 2 units on a scale — p=.35
◆ Published Evidence
Established
36citations · ~6 / year
Relief of pain due to uterine cramping/involution after birth.
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.
Linked Publications
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Relief of pain due to uterine cramping/involution after birth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Level Twenty Four Hours After Delivery |
1; 2 | .35 |
| SECONDARY Number of Patients Taking Additional Pain Medications |
40; 47; 8; 5 | .30 |
| SECONDARY Patient Satisfaction |
4; 5 | .02 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01271855) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.