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Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery?

NCT00488540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2019-04-03

No results posted yet for this study

Summary

There are many reasons for using a vacuum apparatus or forceps to assist in delivering a baby. The traction and pressure on the baby's head due to the vacuum apparatus or forceps may cause pain and discomfort for some time after the delivery. To date, the pain experienced by the newborn and the potential beneficial effects of pain medications after vacuum or forceps deliveries have not been systematically studied. It is possible that administration of paracetamol suppositories to the newborn may be helpful in these situations, since this medication is known to ameliorate pain in older children and adults.

Conditions

Interventions

DRUG

Paracetamol

Suppository

DRUG

Placebos

Suppository

Sponsors & Collaborators

  • Neonatology and Obstetrics, University Hospital Inselspital Berne

    collaborator UNKNOWN

  • University Hospital, Zürich

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Irene Hösli, Prof. Dr. MD · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
1 Hour
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Switzerland

Study Locations

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Entities

Drugs
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 NCT00488540 on ClinicalTrials.gov