Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488540
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2007-06-19
Brief Title:
Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are many reasons for using a vacuum apparatus or forceps to assist in delivering a baby The traction and pressure on the babys 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 Womens University Hospital of Basel the Womens University Hospital of Zurich and the Womens 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 Womens 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
The study will be conducted in the Womens University Hospital of Basel the Womens University Hospital of Zurich and the Womens 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 Womens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None