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New Options for Preoperative Anesthesia in Intrauterine Needling (NO PAIN)

This study has been completed.
Sponsor:
Collaborator:
Leuven University Medical Center
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT01013558
First received: November 10, 2009
Last updated: December 7, 2009
Last verified: November 2009

November 10, 2009
December 7, 2009
September 2004
December 2007   (final data collection date for primary outcome measure)
evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol [ Time Frame: 15-60 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01013558 on ClinicalTrials.gov Archive Site
influence of analgesics (remifentanil) on the fetal stress response [ Time Frame: 15-60 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
New Options for Preoperative Anesthesia in Intrauterine Needling
NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling

The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
  • Stress
  • Pain
  • Drug: Remifentanil
    0.15 microgram/kg/min continuous infusion.
  • Drug: saline
    continuous infusion
  • Active Comparator: remifentanil
    Intervention: Drug: Remifentanil
  • Placebo Comparator: saline
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2007
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • singleton pregnancy
  • clinically indicated intrauterine transfusion
  • red cell alloimmunisation

Exclusion Criteria:

  • severe adipositas
  • suspicion of structural anomalies
  • fetal hydrops
  • contraindication for remifentanil
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01013558
P04.014
No
F.P.H.A. Vandenbussche, MD PhD, Leiden University Medical Center
Leiden University Medical Center
Leuven University Medical Center
Principal Investigator: Frank P.H.A. Vandenbussche, MD PhD Leiden University Medical Center
Leiden University Medical Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP