Pain
Conditions
Keywords
pediatric, gastroscopy, colonoscopy, sedation, ketamine
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.
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.
Interventions
DRUGketamine
0.5mg/kg ketamine iv
Sponsors
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Children =/\> 10 years of age * Undergoing elective diagnostic colonoscopy * ASA score class 1-3.
Exclusion criteria
* Children younger than 10 years of age * Known epilepsy under treatment * ASA score class 4 or more * Interventional colonoscopy (e.g.polypectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score | after one year | pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| necessity of cardiopulmonary intervention (Oxygen requirements) | after one year | according to Observer'sAssessment of Alertness/Sedation (OAAS) score |
Countries
Canada
Outcome results
None listed