Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation

Université de Montréal

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01168492

cme#2857

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 10 to 19 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

ketamine

Experimental group

Description:

group with triple sedation (ketamine, midazolam, meperidine)

Treatment:

Drug: ketamine

placebo

Placebo Comparator group

Description:

group with conventional sedation and placebo ( midazolam, meperidine and placebo)

Treatment:

Drug: ketamine