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Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour

Primary Purpose

Labour Pain, Satisfaction, Adverse Effects

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Remifentanil

About this trial

This is an interventional treatment trial for Labour Pain focused on measuring Remifentanil, parenteral opioids, obstetric analgesia, IVPCA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy women (ASA I-II), in active labour, one fetus with no suspected pathology, expecting normal childbirth, informed consent. Exclusion Criteria: Failure to obtain informed consent, received opioids within last 8 hours before study start, serious side-effects mother and abnormal fetal heart rate.

Sites / Locations

Sorlandet sykehus HF

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Remifentanil IVPCA

Arm Description

Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time

Outcomes

Primary Outcome Measures

Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)

Continuous Visual Analogue Scale 0 - 100 millimeters (0=no pain, 100=worst imaginable pain) Registration of pain scores before start and every 15.minute during treatment with remifentanil. Result given is the maximal change in pain score (mean) compared to the baseline value at the given timepoints.

Secondary Outcome Measures

Patient Satisfaction

Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.

Full Information

NCT ID

NCT00202722

First Posted

September 12, 2005

Last Updated

May 22, 2014

Sponsor

Sorlandet Hospital HF

1. Study Identification

Unique Protocol Identification Number

NCT00202722

Brief Title

Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour

Official Title

Remifentanil as Analgesia for Labour Pain

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sorlandet Hospital HF

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

Detailed Description

Primary and secondary outcome measures presented under "results"

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labour Pain, Satisfaction, Adverse Effects

Keywords

Remifentanil, parenteral opioids, obstetric analgesia, IVPCA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remifentanil IVPCA

Arm Type

Active Comparator

Arm Description

Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time

Intervention Type

Drug

Intervention Name(s)

Remifentanil

Other Intervention Name(s)

Ultiva

Intervention Description

Intravenous patient controlled analgesia (ivpca) during labour

Primary Outcome Measure Information:

Title

Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)

Description

Time Frame

From start with remifentanil treatment until delivery, up to 8 hours.

Secondary Outcome Measure Information:

Title

Patient Satisfaction

Description

Patient satisfaction with remifentanil pain relief by use of questionnaire answered within 24 hours after delivery. Evalutated by a 5-point scale; 1-very satisfied.......5-very dissatisfied.

Time Frame

From start of remifentanil treatment until delivery

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan H. Rosland, Professor

Organizational Affiliation

part time

Official's Role

Study Chair

Facility Information:

Facility Name

Sorlandet sykehus HF

City

Kristiansand

State/Province

Vest-Agder

ZIP/Postal Code

N-4623

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

11517125

Citation

Blair JM, Hill DA, Fee JP. Patient-controlled analgesia for labour using remifentanil: a feasibility study. Br J Anaesth. 2001 Sep;87(3):415-20. doi: 10.1093/bja/87.3.415.

Results Reference

background

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Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour

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