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| Sponsor: | Basel Women’s University Hospital |
|---|---|
| Collaborators: |
Neonatology and Obstetrics, University Hospital Inselspital Berne Neonatology and Obstetrics, University Hospital Zurich |
| Information provided by: | Basel Women’s University Hospital |
| ClinicalTrials.gov Identifier: | NCT00488540 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Paracetamol (Acetaminophen) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery? |
| Estimated Enrollment: | 280 |
| Study Start Date: | June 2007 |
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?
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.
Eligibility| Ages Eligible for Study: | up to 1 Hour |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Eva Maria E Tinner, Dr. med. | eva-maria.tinner@marcellosendos.ch | |
| Contact: Irene Hösli, Prof. Dr. med. | 0041-61-265-90-84 | ihoesli@uhbs.ch |
| Switzerland | |
| Neonatology and Obstetrics, University Hospital Inselspital Berne | Recruiting |
| Berne, Switzerland, 3010 | |
| Contact: Daniel Surbek, Prof. Dr. med. daniel.surbek@insel.ch | |
| Contact: Mathias Nelle, Prof. Dr. med. Mathias.Nelle@insel.ch | |
| Neonatology and Obstetrics, University Hospital Zurich | Recruiting |
| Zurich, Switzerland, 8091 | |
| Contact: Hans U Bucher, Prof. Dr. med. buh@usz.ch | |
| Switzerland, BS | |
| Basel, womens university hospital | Completed |
| Basel, BS, Switzerland, 4031 | |
| Principal Investigator: | Irene Hösli, Prof. Dr. med. | Basel, womens university hospital |
More Information
| Responsible Party: | Basel Women's University Hospital ( Prof. Dr. med. I. Hösli ) |
| Study ID Numbers: | 291/06, 13.894.522, 07.007 |
| Study First Received: | June 19, 2007 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00488540 History of Changes |
| Health Authority: | Switzerland: Swissmedic |
|
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 |
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Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Acetaminophen |