Clinical Trial: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.

Brief Summary:

Sedation is often needed for young children undergoing minor procedures in the emergency department (ED). Oral midazolam is one of the most commonly used regimens for children undergoing laceration repair but its sedative efficacy was shown to be suboptimal. In only one randomized controlled study oral ketamine has been used successfully for procedural sedation for laceration repair. A recent study showed that the combination of oral midazolam and oral ketamine provided deeper sedation compared with oral midazolam alone. However children treated wuth the combination of midazolam and ketamine required longer recovery

Hypothesis:

Oral ketamine can provide superior sedation to oral midazolam in children requiring sedation for laceration repair.


Detailed Summary:
Sponsor: Assaf-Harofeh Medical Center

Current Primary Outcome:

  • Pain score: Visual analog score (VAS)- by a parent [ Time Frame: During the procedure - up to 1 hour ]
    A parent will assess the child's pain on a Visual analog scale
  • Number of patients requiring IV sedation [ Time Frame: During the procedure - up to 1 hour ]
    patients who fail to achieve University of Michigan Sedation Scale (UMSS) of two or higher will be switched to IV sedation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • UMSS - by ED physician [ Time Frame: During the procedure - up to 1 hour ]
  • • VAS by nurse [ Time Frame: During the procedure - up to 1 hour ]
  • Time to reach UMSS > 2 [ Time Frame: up to 1 hour ]
  • • Procedure time [ Time Frame: During the procedure - up to 1 hour ]
  • • Time from procedure to full recovery [ Time Frame: While in the ED - estimated time around 2 hours ]
  • The occurrence of adverse effects during the ED stay [ Time Frame: While in the ED - estimated time around 2 hours ]

    Significant adverse effects are defined as

    1. Oxygen desaturation <92% or hypoventilation requiering ventilatory support
    2. Need for hemodynamic support
    3. Anaphylaxis
    4. Seizures
    5. Any adverse effects requiring patient admission
  • • Patients and parents satisfaction assessed on VAS [ Time Frame: While in the ED - estimated time around 2 hours ]


Original Secondary Outcome: Same as current

Information By: Assaf-Harofeh Medical Center

Dates:
Date Received: July 17, 2013
Date Started: August 2013
Date Completion: July 2014
Last Updated: January 20, 2014
Last Verified: August 2013