Satisfaction Clinical Trial
Official title:
Remifentanil as Analgesia for Labour Pain
Verified date | May 2014 |
Source | Sorlandet Hospital HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Norwegian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | August 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Sorlandet sykehus HF | Kristiansand | Vest-Agder |
Lead Sponsor | Collaborator |
---|---|
Sorlandet Hospital HF |
Norway,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From start with remifentanil treatment until delivery, up to 8 hours. | No |
Secondary | 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. | From start of remifentanil treatment until delivery | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03276741 -
Oral Intake During Labor
|
N/A | |
Enrolling by invitation |
NCT03468608 -
Development and Validation of a Pediatric Procedural Sedation Satisfaction Survey
|
||
Not yet recruiting |
NCT03639012 -
Outcomes of Carbohydrate Loading Paediatric Patients Preoperatively for Tonsillectomy and Adenoidectomy
|
N/A | |
Not yet recruiting |
NCT03267706 -
Introducing the Palliative Care Comprehensive Tool in Family Medicine
|
N/A | |
Completed |
NCT02891187 -
Visits Versus Telephone Calls for Postoperative Care
|
N/A | |
Completed |
NCT02619474 -
The Effect of Whiteboards on Patient Satisfaction
|
N/A | |
Recruiting |
NCT04091152 -
TIKeasy TAblet satisfaCtion (TikTac)
|
||
Completed |
NCT03269240 -
Simulation-based Low-dose High Frequency (LDHF) Plus Mobile Mentoring (m-Mentoring) Study in Nigeria
|
N/A | |
Withdrawn |
NCT04103827 -
Qoos Use Sustaining Health Among patIents hOspitalized in Geriatric mediciNe (QUSHION)
|
||
Not yet recruiting |
NCT05494684 -
Effectiveness of Multisensoral Nature-based Intervention in Hospitalized Children During Venous Blood Sampling
|
N/A | |
Recruiting |
NCT04608968 -
Pediatric Perioperative Satisfaction Questionnaire
|
||
Completed |
NCT03480516 -
Comparison of Caries Arrested & Prevented Among SDF, NaF Varnish and Combination in Children
|
N/A | |
Completed |
NCT03708874 -
Pain Management of Emergency Laparoscopic Cholecystectomy in Patients With Acute Cholecystitis
|
||
Completed |
NCT02770742 -
Patient Satisfaction With Sedated vs. Unsedated Colonoscopy
|
||
Completed |
NCT02830802 -
Clinical Trial for Evaluating Sage-Based Mouthrinse
|
N/A | |
Completed |
NCT02734056 -
Music During Labor Epidural Placement and Patient Satisfaction
|
N/A | |
Completed |
NCT01038882 -
Randomized Study With Midazolam for Sedation in Flexible Bronchoscopy
|
N/A | |
Recruiting |
NCT05813197 -
Leaving Care - a Comparison Study of Implementation, Change Mechanisms, and Effects of Transition Services for Youth Leaving Out-of-home Care
|
N/A | |
Completed |
NCT03844659 -
Music's Effects on Anxiety During Epidural Placement
|
N/A | |
Active, not recruiting |
NCT05931432 -
A Tailored and Digital Approach to Address Equity and Support Well-being for Healthcare Workers in the Era of COVID
|
N/A |