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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketamine | Experimental | group with triple sedation (ketamine, midazolam, meperidine) |
|
| placebo | Placebo Comparator | group with conventional sedation and placebo ( midazolam, meperidine and placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine | Drug | 0.5mg/kg ketamine iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain score | pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year | after one year |
| Measure | Description | Time Frame |
|---|---|---|
| necessity of cardiopulmonary intervention (Oxygen requirements) | according to Observer'sAssessment of Alertness/Sedation (OAAS) score | after one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Herzog, MD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sainte Justine Hospital | Montreal | Quebec | H3T1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15114309 | Background | Gilger MA, Spearman RS, Dietrich CL, Spearman G, Wilsey MJ Jr, Zayat MN. Safety and effectiveness of ketamine as a sedative agent for pediatric GI endoscopy. Gastrointest Endosc. 2004 May;59(6):659-63. doi: 10.1016/s0016-5107(04)00180-4. | |
| 18440381 | Background | McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046. |
| Label | URL |
|---|---|
| research center of Sainte Justine Hospital | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |