The aim of this study was to assess the clinical efficacy of combined treatment with local anesthesia and ketamine procedural sedation for pediatric facial laceration repair in the emergency department (ED).

Is Local Anesthesia Necessary in Ketamine Sedation for Pediatric Facial Laceration Repair in the Emergency Department?: Randomized, Controlled Trial of Efficacy and Safety

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000546

Enrollment

282

Registered

2012-09-28

Start date

2012-09-17

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Initially, all patients will be to receive intravenous (IV) ketamine (2 mg/kg). Subsequently, they will be randomly divided into 2 groups(Probability sampling-Simple random): the Local anesthes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pediatric patients in the ED aged 1-5 years receiving ketamine for facial laceration repair

Exclusion criteria

Exclusion criteria: acute or chronic pulmonary infection or cardiovascular disease, including hypertension; head injury associated with loss of consciousness, altered mental status, or emesis; central nervous system mass lesions, hydrocephalus, and other conditions associated with intracranial hypertension; glaucoma or acute globe injury; prior adverse reaction to ketamine

Design outcomes

Primary

Measure	Time frame
length of sedation;groan;spontaneous movement;salivation;vomiting;respiration	—

Secondary

Measure	Time frame
satisfaction ratings of physicians, nurses, and parents ;satisfaction ratings of nurses;satisfaction ratings of parents	—

Countries

Korea, Republic of

Contacts

Public ContactJae Hyung Choi

Soon Chun Hyang University Hospital Seoul

Outcome results