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Alfentanil in CT-colonography.

A randomized double-blind placebo controlled trial to evaluate the value of a single bolus intravenous alfentanil in CT-colonography.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25320
Enrollment
90
Registered
2011-05-17
Start date
2011-05-19
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

Pain Ct-colonography Colorectal cancer Polyps

Interventions

Subjects randomised to group 1 will receive alfentanil (Rapifen
Janssen-Cilag, Tilburg, The Netherlands) 7.5 ìg/kg intravenously through a 20 Gauge intravenous cannula. Subjects randomised to group 2 will receive a placebo, in this study a 0.9% saline solution thr

Sponsors

Academic Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 to 85 years; 2. Written informed consent; 3. Sceduled for CT-colonography for symptoms or increased risk for colorectal cancer.

Exclusion criteria

Exclusion criteria: 1. Hypotension (systolic pressure 4); 7. Use of MAO inhibitor or in 2 weeks before CT-colonography; 7. Use of barbiturates, opiates or daily benzodiazepine use; 8. Known increased intracranial pressure.

Design outcomes

Primary

MeasureTime frame
The difference between the alfentanil group and placebo group in maximum pain score during insufflation.

Secondary

MeasureTime frame
1. Pain score in all insufflation positions (left and right decubitus, supine and prone) and the average pain score; 2. Pain and burden of all CT-colonography aspects (telebrix, cannula insertion, rectal catheter insertion, insufflation, turing on scanner table, post-procedure) and total pain and burden of CT-colonography; 3. Side-effects of alfentanil during CT-colonography including: A. Respiratory effects (apnoea, respiratory frequency and blood oxygenation); B. Hemodynamics (heart rate and blood pressure). 4. Procedure and recovery time; 5. The most painful and most burdenful aspect of CT-colonography.

Contacts

Public ContactJ. Stoker

Academic Medical Center Radiology department Meibergdreef 9

j.stoker@amc.uva.nl+31 (0)20 5662532

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)