PainPhase 4NCT00488540
Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery?
A Phase 4 study testing Paracetamol in people with Pain, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 minutes to 1 hourHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jun 2007to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 minutes to 1 hour
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Multiples
- Fetal malformation
- Systemic opiates within 24 hours before birth
- Ambulatory birth (mother and child leave the hospital a few hours after birth)
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital Basel
Basel, Canton of Basel-City, 4031
Neonatology and Obstetrics, University Hospital Inselspital Berne
Bern, 3010
Neonatology and Obstetrics, University Hospital Zurich
Zurich, 8091
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Paracetamol, Placebos
- 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
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Suppository
PlacebosDrug
Suppository
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol (Acetaminophen) | Active comparator | 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. Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pain reaction using the EDIN scale on the first day of life and evaluation of the stress-reaction after the Guthrie test with duration of crying, saliva cortisol and "Bernese Pain Scale for Neonates"
Secondary outcomes (1)
Validation of the Bernese Pain Scale for Neonates and the EDIN scale. Comparison between different types of vacuum extractors in view of neonatal pain. Comparison of different modes of delivery in view of neonatal pain and stress-reaction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Neonatology and Obstetrics, University Hospital Inselspital Berne, University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Irene Hösli, Prof. Dr. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488540
- Sponsor's protocol ID
- 291/06
- Status last verified
- Apr 2019
- First submitted
- 19 Jun 2007
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Debillon T, Zupan V, Ravault N, Magny JF, Dehan M. Development and initial validation of the EDIN scale, a new tool for assessing prolonged pain in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2001 Jul;85(1):F36-41. doi: 10.1136/fn.85.1.f36.
PubMed 11420320Cignacco E, Mueller R, Hamers JP, Gessler P. Pain assessment in the neonate using the Bernese Pain Scale for Neonates. Early Hum Dev. 2004 Jul;78(2):125-31. doi: 10.1016/j.earlhumdev.2004.04.001.
PubMed 15223117Schuller C, Kanel N, Muller O, Kind AB, Tinner EM, Hosli I, Zimmermann R, Surbek D. Stress and pain response of neonates after spontaneous birth and vacuum-assisted and cesarean delivery. Am J Obstet Gynecol. 2012 Nov;207(5):416.e1-6. doi: 10.1016/j.ajog.2012.08.024. Epub 2012 Aug 17.
PubMed 22959831Tinner EM, Hoesli I, Jost K, Schobi N, Ulrich Megged Y, Burkhardt T, Krafft A, Bucher HU, Surbek D, Nelle M, Buhrer C. Rectal paracetamol in newborn infants after assisted vaginal delivery may increase pain response. J Pediatr. 2013 Jan;162(1):62-6. doi: 10.1016/j.jpeds.2012.06.020. Epub 2012 Jul 17.
PubMed 22809664Huhn EA, Visca E, Vogt DR, von Felten S, Tinner Oehler EM, Buhrer C, Surbek D, Zimmermann R, Hoesli I. Decreased neonatal pain response after vaginal-operative delivery with Kiwi OmniCup versus metal ventouse. BMC Pregnancy Childbirth. 2017 Jan 31;17(1):47. doi: 10.1186/s12884-017-1231-x.
PubMed 28143599
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery?
- ClinicalTrials.gov ID
- NCT00488540
- Acronym / sponsor ID
- 291/06
- Conditions
- Pain
- Keywords
- newborn, infant, pain, acetaminophen, paracetamol, mode of delivery, vacuum extraction, forceps extraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Neonatology and Obstetrics, University Hospital Inselspital Berne, University Hospital, Zürich
- Study start
- Jun 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol (Acetaminophen) | Active comparator | Drug: ParacetamolParacetamol (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. |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo 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. |
Who may qualify
- Ages
- 30 minutes to 1 hour
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Multiples
- Fetal malformation
- Systemic opiates within 24 hours before birth
- Ambulatory birth (mother and child leave the hospital a few hours after birth)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: AcetaminophenSuppository | Drug | Paracetamol (Acetaminophen) |
| PlacebosSuppository | Drug | Placebo |
Primary outcome
Measurement of pain reaction using the EDIN scale on the first day of life and evaluation of the stress-reaction after the Guthrie test with duration of crying, saliva cortisol and "Bernese Pain Scale for Neonates"
1 secondary outcome
Validation of the Bernese Pain Scale for Neonates and the EDIN scale. Comparison between different types of vacuum extractors in view of neonatal pain. Comparison of different modes of delivery in view of neonatal pain and stress-reaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
- Background: PubMed 11420320Debillon T, Zupan V, Ravault N, Magny JF, Dehan M. Development and initial validation of the EDIN scale, a new tool for assessing prolonged pain in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2001 Jul;85(1):F36-41. doi: 10.1136/fn.85.1.f36.
- Background: PubMed 15223117Cignacco E, Mueller R, Hamers JP, Gessler P. Pain assessment in the neonate using the Bernese Pain Scale for Neonates. Early Hum Dev. 2004 Jul;78(2):125-31. doi: 10.1016/j.earlhumdev.2004.04.001.
- Results publication: PubMed 22959831Schuller C, Kanel N, Muller O, Kind AB, Tinner EM, Hosli I, Zimmermann R, Surbek D. Stress and pain response of neonates after spontaneous birth and vacuum-assisted and cesarean delivery. Am J Obstet Gynecol. 2012 Nov;207(5):416.e1-6. doi: 10.1016/j.ajog.2012.08.024. Epub 2012 Aug 17.
- Results publication: PubMed 22809664Tinner EM, Hoesli I, Jost K, Schobi N, Ulrich Megged Y, Burkhardt T, Krafft A, Bucher HU, Surbek D, Nelle M, Buhrer C. Rectal paracetamol in newborn infants after assisted vaginal delivery may increase pain response. J Pediatr. 2013 Jan;162(1):62-6. doi: 10.1016/j.jpeds.2012.06.020. Epub 2012 Jul 17.
- Results publication: PubMed 28143599Huhn EA, Visca E, Vogt DR, von Felten S, Tinner Oehler EM, Buhrer C, Surbek D, Zimmermann R, Hoesli I. Decreased neonatal pain response after vaginal-operative delivery with Kiwi OmniCup versus metal ventouse. BMC Pregnancy Childbirth. 2017 Jan 31;17(1):47. doi: 10.1186/s12884-017-1231-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Hösli, Prof. Dr. MD principal investigator
University Hospital, Basel, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol in people with Pain, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pain reaction using the EDIN scale on the first day of life and evaluation of the stress-reaction after the Guthrie test with duration of crying, saliva cortisol and "Bernese Pain Scale for Neonates". It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488540, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2019.