Clinical trial NCT01925898: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Official title: A Randomized, Clinical Trial of Oral Midazolam Versus Oral Ketamine for Sedation During Laceration Repair.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lacerations
Keywords: Laceration
Sedation
Pediatrics
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

• Any child with laceration requiring sedation

Exclusion Criteria:

* Major trauma
* Closed head injury associated with loss of consciousness
* Abnormal neurologic examination in a previously normal child
* Significant developmental delay or baseline neurological deficit
* A patient with seizures
* Elevated intra-cranial pressure
* Hypersensitivity to midazolam or ketamine
* Hypertension
* Hyperthyroidism or a patient receiving thyroid replacement
* alcohol intoxication or a history of alcohol abuse
* Acute or chronic respiratory, cardiac, renal or hepatic abnormalities
* Glaucoma
* Known psychiatric disease
* American Society of Anesthesiologists (ASA) score of more than 2
* Informed consent cannot be obtained from legal guardian

Primary outcomes:
measure: Pain score: Visual analog score (VAS)- by a parent
timeFrame: During the procedure - up to 1 hour
measure: Number of patients requiring IV sedation
timeFrame: During the procedure - up to 1 hour
Secondary outcomes:
measure: UMSS - by ED physician
timeFrame: During the procedure - up to 1 hour
measure: • VAS by nurse
timeFrame: During the procedure - up to 1 hour
measure: Time to reach UMSS > 2
timeFrame: up to 1 hour
measure: • Procedure time
timeFrame: During the procedure - up to 1 hour
measure: • Time from procedure to full recovery
timeFrame: While in the ED - estimated time around 2 hours
measure: The occurrence of adverse effects during the ED stay
timeFrame: While in the ED - estimated time around 2 hours
measure: • Patients and parents satisfaction assessed on VAS
timeFrame: While in the ED - estimated time around 2 hours
Other outcomes:
Locations:
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh MC
Study officials:
References: