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

April 1, 2019 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

How will this study be conducted?

The study will be conducted in the Women's University Hospital of Basel, the Women's University Hospital of Zurich and the Women's University Hospital of Bern. Newborn infants born with the aid of a vacuum or forceps will be included, with the explicit permission of their parents. The children will receive a rectal suppository, which will be prepared by the pharmacy at the Women's University Hospital of Basel, at two and eight hours of postnatal age. These children will receive either paracetamol or a placebo, which will be randomly assigned. The doctors, the midwives, nurses and other people involved in the care of the child will not know which medication had been given. Only the pharmacy has access to this information, which can be obtained only in emergency situations. The child will be regularly monitored for signs of pain or discomfort.

In Switzerland, all newborn babies are tested at three days of age for thyroid and other rare but treatable diseases by taking a blood sample from the heel. Newborns that participate in this study will be observed after this blood draw to see how long they show signs of pain or discomfort. In addition, sputum tests before and after the blood draw will be taken in order to measure the level of cortisone (a measurement of stress).

What measures will be performed?

  • Two suppositories, either with or without paracetamol, will be administered (only to children in the study group, that is, those that were born with the aid of a vacuum or forceps).
  • On the first day of life, at 2, 4, 8, 12 and 24 hours after delivery, a midwife or nurse will examine the newborn (EDIN scale) and determine if he or she has pain, and if so, will indicate how strong the pain appears to be.
  • On the fourth day of life, at the same time that the standard blood screening tests for metabolic diseases are performed, a saliva test to identify the stress hormone cortisol will be taken before and after the blood tests and the pain reaction will be measured. The length of time that the child cries after the blood test has been performed will be observed and filmed, in order to more accurately determine the duration of the crying. This film will be destroyed after the study has been completed.
  • As with all other newborns, we will give the child a small amount of sugar solution before taking the blood sample to reduce the pain. The efficacy of this measure has been well documented.

No child will have additional blood tests outside of the routinely performed screening tests through participation in this study.

In order to determine whether babies born by caesarean section or without any assistance through instruments such as vacuum or forceps experience less pain and have a less dramatic stress reaction, we will enroll also children, who were born without the aid of one of these instruments, for observation in this study. They will not receive any medication.

Study Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3010
        • Neonatology and Obstetrics, University Hospital Inselspital Berne
      • Zurich, Switzerland, 8091
        • Neonatology and Obstetrics, University Hospital Zurich
    • BS
      • Basel, BS, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborns after vacuum or forceps extraction for paracetamol or placebo
  • Newborns after vaginal delivery or cesarean section as observational group
  • Gestational age at or above 35 weeks
  • Birthweight above 2000g
  • Signed informed consent of parents

Exclusion Criteria:

  • Multiples
  • Fetal malformation
  • Systemic opiates within 24 hours before birth
  • Ambulatory birth (mother and child leave the hospital a few hours after birth)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paracetamol (Acetaminophen)
Paracetamol (Acetaminophen) given at 2 and 8 hours post birth, measurement of EDIN-Score on day one of life, measurement of stress response after Guthrie-test on day 4 of life.
Drug: Paracetamol
Suppository
Other Names:
  • Acetaminophen
Placebo Comparator: Placebo
Placebo given at 2 and 8 hours post birth, measurement of EDIN-Score on day one of life, measurement of stress response after Guthrie-test on day 4 of life.
Drug: Placebos
Suppository

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measurement of pain reaction using the EDIN scale on the first day of life and evaluation of the stress-reaction after the Guthrie test with duration of crying, saliva cortisol and "Bernese Pain Scale for Neonates"

Secondary Outcome Measures

Outcome Measure
Validation of the Bernese Pain Scale for Neonates and the EDIN scale. Comparison between different types of vacuum extractors in view of neonatal pain. Comparison of different modes of delivery in view of neonatal pain and stress-reaction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital, Zürich
Neonatology and Obstetrics, University Hospital Inselspital Berne

Investigators

  • Principal Investigator: Irene Hösli, Prof. Dr. MD, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

June 19, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

April 1, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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