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

NCT00488540 | Completed Phase 4

• 1 other identifier: 291/06
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Pain

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

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.

Drug: Placebos

Interventions

Paracetamol DRUG

Suppository

Also known as: Acetaminophen

Paracetamol (Acetaminophen)

Placebos DRUG

Suppository

Placebo

Eligibility Criteria

• Age: 30 Minutes - 1 Hour
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Multiples
• Fetal malformation
• Systemic opiates within 24 hours before birth
• Ambulatory birth (mother and child leave the hospital a few hours after birth)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Neonatology and Obstetrics, University Hospital Inselspital Berne: collaborator
• University Hospital, Zürich: collaborator

Study Sites (3)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Neonatology and Obstetrics, University Hospital Inselspital Berne

Bern, 3010, Switzerland

Location

Neonatology and Obstetrics, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 11420320 BACKGROUND

• Cignacco 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.

  PMID: 15223117 BACKGROUND

• Schuller 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.

  PMID: 22959831 RESULT

• Tinner 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.

  PMID: 22809664 RESULT

• Huhn 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.

  PMID: 28143599 RESULT

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Irene Hösli, Prof. Dr. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

CH (3)