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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Basel Women’s University Hospital; University Hospital, Basel, Switzerland
• Collaborators: Neonatology and Obstetrics, University Hospital Inselspital Berne; Neonatology and Obstetrics, University Hospital Zurich; University Hospital, Zürich
• Treatments: Acetaminophen

Criteria

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)