Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Université de Montréal.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Université de Montréal
Information provided by:
Université de Montréal
ClinicalTrials.gov Identifier:
NCT01168492
First received: July 21, 2010
Last updated: July 22, 2010
Last verified: July 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 21, 2010 | ||||||||
| Last Updated Date | July 22, 2010 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
pain score [ Time Frame: after one year ] [ Designated as safety issue: No ] pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01168492 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
necessity of cardiopulmonary intervention (Oxygen requirements) [ Time Frame: after one year ] [ Designated as safety issue: Yes ] according to Observer'sAssessment of Alertness/Sedation (OAAS) score |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: ketamine
0.5mg/kg ketamine iv
Other Name: no other names |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 10 Years to 19 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01168492 | ||||||||
| Other Study ID Numbers ICMJE | cme#2857 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Denise Herzog, University of Montreal | ||||||||
| Study Sponsor ICMJE | Université de Montréal | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Université de Montréal | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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