Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery?
Condition: Pain
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Paracetamol; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Suppository; Suppository
Other intervention name(s): Acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: newborn; infant; pain; acetaminophen; paracetamol; mode of delivery; vacuum extraction; forceps extraction; cesarean section; EDIN scale; Bernese Pain Scale for Neonates; pain after different modes of delivery in newborn infants; efficacy of acetaminophen as analgesia for newborn infants