Assessing Maternal Post-partum Pain With Suppositories

NCT01271855 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-03-07

Study results available
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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.

Conditions

Interventions

DRUG

Belladonna and opioid suppository

Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery

DRUG

Glycerin Suppository

A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Kimberly Kenton, M.D. · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-22
Primary Completion
2011-09-29
Completion
2011-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01271855 on ClinicalTrials.gov