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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
0.5mg/kg ketamine iv
Sainte Justine Hospital
Montreal, Quebec, Canada
pain score
pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year
Time frame: after one year
necessity of cardiopulmonary intervention (Oxygen requirements)
according to Observer'sAssessment of Alertness/Sedation (OAAS) score
Time frame: after one year
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