Trial Outcomes & Findings for Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour (NCT NCT00202722)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

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

Results posted on

2014-06-23

Participant Flow

Recruited at arrival to the Labour department

Participant milestones

Participant milestones
Measure	Effect and Side Effects of Remifentanil Analgesic efficacy and side offects of remifentanil during labour and delivery
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women in Labour Given Remifentanil Analgesia n=41 Participants Administration of remifentanil analgesia startet with cervical dilatation \> 4 cm
Region of Enrollment Norway	41 participants n=5 Participants
Age, Continuous	27 years n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

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

Population: Per protocol

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.

Outcome measures

Outcome measures
Measure	Remifentanil n=41 Participants Pain scores Satisfaction
Pain Score, Visual Analogue Scale (VAS) (Mean Maximal Change in Pain)	47 millimeters Standard Deviation 20.2 • Interval 60.0 to 93.0

SECONDARY outcome

Timeframe: From start of remifentanil treatment until delivery

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.

Outcome measures

Outcome measures
Measure	Remifentanil n=41 Participants Pain scores Satisfaction
Patient Satisfaction	37 Participants

Adverse Events

Maternal Oxygen Desaturation

Serious events: 11 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Maternal Oxygen Desaturation n=41 participants at risk Oxygen saturation lower than 92% during labour and delivery
Respiratory, thoracic and mediastinal disorders Oxygen saturation lower than 92%	26.8% 11/41 • Number of events 11 • From start of remifentanil analgesia until delivery Continuous monitoring of oxygen saturation

Other adverse events

Other adverse events
Measure	Maternal Oxygen Desaturation n=41 participants at risk Oxygen saturation lower than 92% during labour and delivery
Nervous system disorders Maternal sedation	53.7% 22/41 • Number of events 22 • From start of remifentanil analgesia until delivery Continuous monitoring of oxygen saturation

Additional Information

Tor Tveit

Sorlandet Hospital HF

Phone: +4738073608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place