Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
Brief Summary
The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.
Study Design
| Study type: | Interventional |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 10 Years to 19 Years (Child, Adult) |
| Enrollment: | 90 () |
| Funded by: | Other |
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Clinical Trial Dates
| Start date: | Jul 10, 2020 | |
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| Primary Completion: | Jul 13, 2020 | |
| Completion Date: | Jul 13, 2020 | |
| Study First Posted: | Jul 23, 2010 | |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Dec 04, 2014 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 10 |
| Maximum Age: | 19 |
More Details
| NCT Number: | NCT01168492 |
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| Other IDs: | cme#2857 |
| Study URL: | https://ClinicalTrials.gov/show/NCT01168492 |
Last updated: Feb 22, 2021