New Options for Preoperative Anesthesia in Intrauterine Needling (NO PAIN)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stress Pain |
Drug: Remifentanil Drug: saline |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling |
- 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 ]
- influence of analgesics (remifentanil) on the fetal stress response [ Time Frame: 15-60 minutes ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: remifentanil |
Drug: Remifentanil
0.15 microgram/kg/min continuous infusion.
|
| Placebo Comparator: saline |
Drug: saline
continuous infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- singleton pregnancy
- clinically indicated intrauterine transfusion
- red cell alloimmunisation
Exclusion Criteria:
- severe adipositas
- suspicion of structural anomalies
- fetal hydrops
- contraindication for remifentanil
Contacts and Locations| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 RC | |
| Principal Investigator: | Frank P.H.A. Vandenbussche, MD PhD | Leiden University Medical Center |
More Information
No publications provided
| Responsible Party: | F.P.H.A. Vandenbussche, MD PhD, Leiden University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01013558 History of Changes |
| Other Study ID Numbers: | P04.014 |
| Study First Received: | November 10, 2009 |
| Last Updated: | December 7, 2009 |
| Health Authority: | Netherlands: Medical Ethics Committee |
Keywords provided by Leiden University Medical Center:
|
fetal pain intrauterine needling |
Additional relevant MeSH terms:
|
Anesthetics Remifentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on May 23, 2013