NCT01271855

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Jul 2009

Typical duration for phase_4 pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2011

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

February 6, 2018

Completed
Last Updated

March 7, 2018

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

January 5, 2011

Results QC Date

January 8, 2018

Last Update Submit

February 5, 2018

Conditions

Pain

Keywords

BelladonnaOpiumSuppository

Outcome Measures

Primary Outcomes (1)

  • Pain Level Twenty Four Hours After Delivery

    The primary outcome is pain measured at 24-hours after delivery. Patients will be asked to report a Visual Analog Scale (VAS) pain score at 24-hours after delivery. This scale ranges from 0 to 10 (0=no pain and 10=worst pain).

    Twenty-four hours

Secondary Outcomes (2)

  • Number of Patients Taking Additional Pain Medications

    Twenty-four hours

  • Patient Satisfaction

    Discharge

Study Arms (2)

Glycerin suppository

PLACEBO COMPARATOR

Women assigned to this arm receive a glycerin suppository (placebo) every 8 hours after delivery during the first 24 hours postpartum

Drug: Glycerin Suppository

Belladonna and opioid suppository

EXPERIMENTAL

Women assigned to this arm receive a belladonna and opioid (B\&O) suppository every 8 hours after delivery during the first 24 hours postpartum

Drug: Belladonna and opioid suppository

Interventions

Belladonna and opioid suppositoryDRUG

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

Belladonna and opioid suppository
Glycerin SuppositoryDRUG

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

Glycerin suppository

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loyola Univeristy Medical Center

Maywood, Illinois, 60153, United States

Location

Gottlieb Memorial Hospital

Melrose Park, Illinois, 60160, United States

Location

Related Publications (8)

  • Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.

    PMID: 15507941BACKGROUND

  • Wilasrusmee S, Chittachareon A, Jirasiritum S, Srisangchai P. Naproxen suppository for perineal pain after vaginal delivery. Int J Gynaecol Obstet. 2008 Jul;102(1):19-22. doi: 10.1016/j.ijgo.2008.01.015. Epub 2008 Mar 5.

    PMID: 18321517BACKGROUND

  • Searles JA, Pring DW. Effective analgesia following perineal injury during childbirth: a placebo controlled trial of prophylactic rectal diclofenac. Br J Obstet Gynaecol. 1998 Jun;105(6):627-31. doi: 10.1111/j.1471-0528.1998.tb10177.x.

    PMID: 9647153BACKGROUND

  • Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. doi: 10.1002/14651858.CD003931.

    PMID: 12917995BACKGROUND

  • Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002 Jul;20(4):287-90. doi: 10.1053/ajem.2002.33778.

    PMID: 12098173BACKGROUND

  • Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

    PMID: 11733293BACKGROUND

  • DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020.

    PMID: 9428860BACKGROUND

  • Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.

    PMID: 33078388DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

There are no limitations or caveats to report

Results Point of Contact

Title
Kimberly Kenton MD, MS
Organization
Northwestern University
kkenton@nm.org
312-472-3874

Study Officials

  • Kimberly Kenton, M.D.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to receive either a belladonna and opioid suppository or a glycerin suppository (placebo) every eight hours after delivery during the first 24 hours after delivery using a 1:1 allocation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 7, 2011

Study Start

July 22, 2009

Primary Completion

September 29, 2011

Study Completion

September 29, 2011

Last Updated

March 7, 2018

Results First Posted

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data.

Locations

US(2)