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BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.
OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.
PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.
Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.
Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Experimental |
| |
| Paracetamol | Active Comparator | intravenous paracetamol 1g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remifentanil | Drug | intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of decrease in pain experienced by patients during the maneuver according to the VAS | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section. | 1 day | |
| Number of adverse events and severity | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cesar A Valero, MD | Basque Health Service | Principal Investigator |
| Henar Muñoz, MD | Basque Health Service | Study Chair |
| Amanda Lopez | Basque Health Service | Study Chair |
| Sandra Guerra, MD | Basque Health Service | Study Chair |
| Olga Echebarria, MD | Basque Health Service | Study Chair |
| Alfonso Velasco, MD | University of Valladolid | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Txagorritxu | Vitoria-Gasteiz | Alava | 01009 | Spain |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| paracetamol | Drug | Control group: intravenous paracetamol 1g |
|
|
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |