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

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Placebos; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT00488540

291/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 estimated patients

Sex: All

Ages: 30 minutes to 1 hour old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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280 participants in 2 patient groups, including a placebo group

Paracetamol (Acetaminophen)

Active Comparator group

Description:

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.

Treatment:

Drug: Paracetamol

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos