Patient-controlled remifentanil analgesia during oocyte retrieval for IVF/ICSI procedures.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26955

Enrollment

Registered

2010-07-27

Start date

2010-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women undergoing IVF/ICSI procedures Oocyte retrieval Pain

Interventions

Standard therapy will consist of routine conscious sedation with midazolam (7.5 mg per os) and pethidine (2 mg/kg bodyweight i.m.). Both medications will be administered 30 minutes before the puncture

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female subjects who undergo elective IVF/ICSI; 2. Age 18-45 years; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Not willing to receive analgesia; 2. Allergy for remifentanil or pethidine.

Design outcomes

Primary

Measure	Time frame
1. Pain levels and as measured by 0-10 numeric rating scale (NRS); 2. SpO2, heart rate and blood pressure during oocyte retrieval; 3. Pain levels in the first 4 days post-puncture. A pain intensity score calculated from an average of 12 ratings across 4 days demonstrated adequate reliability and excellent validity as a measure of the average pain. Furthermore, pain scores in the post-puncture period will be monitored using the McGill pain questionnaire.	—

Measure

Time frame

1. Pain levels and as measured by 0-10 numeric rating scale (NRS); 2. SpO2, heart rate and blood pressure during oocyte retrieval; 3. Pain levels in the first 4 days post-puncture. A pain intensity score calculated from an average of 12 ratings across 4 days demonstrated adequate reliability and excellent validity as a measure of the average pain. Furthermore, pain scores in the post-puncture period will be monitored using the McGill pain questionnaire.

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Secondary

Measure	Time frame
1. Difference in pain between patients with or without endometriosis; 2. Difference in puncture pain between left- and right ovary; 3. Pain predictors including the expected pain levels, anxiety and pre-procedure pain; 4. Pain scores in the first 4 days post-puncture; 5. Level of sedation according to the Ramsey sedation scale; 6. Use of post-puncture pain medication; 7. Pregnancy rate; 8. Treatment costs; 9. Patient satisfaction with the analgesic method.	—

Measure

Time frame

1. Difference in pain between patients with or without endometriosis; 2. Difference in puncture pain between left- and right ovary; 3. Pain predictors including the expected pain levels, anxiety and pre-procedure pain; 4. Pain scores in the first 4 days post-puncture; 5. Level of sedation according to the Ramsey sedation scale; 6. Use of post-puncture pain medication; 7. Pregnancy rate; 8. Treatment costs; 9. Patient satisfaction with the analgesic method.

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Contacts

Public ContactChrista Boer

VU University Medical Center, Department of Anesthesiology

c.boer@vumc.nl+31 (0)20 4443830

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)