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Completed

NCT Number: NCT01168492

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

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sainte Justine Hospital

Montreal, Quebec, H3T1C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ketamine

Drug

0.5mg/kg ketamine iv

Other names: no other names

Primary outcomes

  1. pain score

    Time frame: 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 outcomes

  1. necessity of cardiopulmonary intervention (Oxygen requirements)

    Time frame: after one year

    according to Observer'sAssessment of Alertness/Sedation (OAAS) score

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 23, 2010
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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