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Completed

NCT Number: NCT02732132

A Comparison of the Sedation During Endoscopy in Children

The primary aim of this study was to investigate the efficiency and safety of midazolam plus ketamine versus fentanyl plus propofol administered to children undergoing UGE and to determine the most appropriate sedation protocol.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

The patients were given a spray of lidocaine 10% as a topical pharyngeal anaesthesia before sedation. Intravenous midazolam bolus dose 0.1 mg/kg (maximum 4 mg) was administered to Group A. Two minutes later, ketamine bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after ketamine application. Ketamine 0.5 mg/kg (maximum of 2 mg/kg) was added in two minute intervals if adequate sedation was not achieved initially. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a ketamine 0.5 mg/kg single dose was applied. Intravenous fentanyl bolus dose 1µg/kg was administered to Group B. Two minutes later, propofol bolus dose 1 mg/kg was given intravenously. Patient responses to verbal and tactile stimuli were evaluated two minutes after propofol application. Propofol 0.5 mg/kg was added in two minute intervals if adequate sedation was not achieved. The endoscopy process was initiated by the endoscopist if there was no response. If the patients were agitated after the procedure started, a propofol 0.5 mg/kg single dose was applied. None of the patients were given an antidote after the process during recovery.

All patients were monitored for peripheral oxygen saturation, heart rate (HR), respiratory rate, and RSS during the procedure. Oxygen (2L/min) by nasal cannula was given to all patients during the procedure. Hypoxia (peripheral oxygen saturation <90% during 60 seconds), apnea, laryngospasm, tachycardia (defined as 30% more than the average heart rate by age), bradycardia (30% less than the average heart rate by age), increase in oral secretions (more than enough to warrant aspiration), flushing, coughing and vomiting were assessed as complications and recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All the patients were in ASA (American Society of Anesthesiologists) physical status I or II.

Exclusion criteria

  • Patients with respiratory tract infections, glaucoma, psychosis, porphyria, hypertension, metabolic or neurologic diseases, increased intracranial pressure and intracranial mass, and patients known to be allergic to the drugs used were excluded from the study.

Treatment and study plan

Ketamine and Midazolam

Drug

This group was injected intravenous midazolam 0.1 mg/kg (maximum 4 mg), two minutes later, ketamine 1 mg/kg was given intravenously before the start of endoscopy.

Other names: Ketalar (Ketamin, Pfizer) and Dormicum (Midazolam, Roche)

Propofol and Fentanyl

Drug

This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.

Other names: Propofol Lipuro (Propofol, B-Braun) Fentanyl (Fentanyl, J&J)

Primary outcomes

  1. the effectiveness of sedation

    Time frame: six months

    the effectiviness of midazolam plus ketamine versus fentanyl plus propofol according to a modified Ramsay sedation score

Secondary outcomes

  1. adverse events that are related to study drugs

    Time frame: six months

    number of patients with adverse events that are related to study drugs

  2. procedure time

    Time frame: six months

    procedure time is defined as the time between the insertion of endoscope and removal of endoscope

  3. recovery time

    Time frame: six months

    recovery time is defined as the time from completing the endoscopy to achieving Aldrete score 10 in the recovery unit Aldrete score

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

A Comparison of the Sedation With Intermittent Bolus Midazolam-Ketamine Versus Intermittent Bolus Propofol-Fentanyl During Endoscopy in Children: Randomized Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 8, 2016
Registry last updated
Apr 11, 2016

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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