Intranasal Ketamine as a Sedative for Venipuncture

Hospital de Clinicas de Porto Alegre

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diseases of the Digestive System; Acute Pain; Respiratory Tract Disease

Treatments: Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02929524

150424

Details and patient eligibility

About

Randomized clinical trial, controlled, double-blind, parallel two-arm.

Full description

Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.

Enrollment: 39 patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
• Aged 3 months to 12 years;
• Requiring venipuncture independent research.

Exclusion criteria

• Severe neurological sequelae;
• Patients who need immediate venipuncture at risk;
• Presence of active nosebleeds;
• Patients using drugs sedative and analgesic continuos;
• Children who have experienced clinical change with ketamine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups, including a placebo group

Ketamine group

Experimental group

Description:

This group was used intranasal ketamine, syringes were made with 4 ml of the drug (50mg/ml), 1 randomized per patient. The validity stability and were 7 days after drawing the solution. The drug began to take effect in 10 minutes and lasted about 40 minutes.

Treatment:

Drug: Ketamine

Placebo Group

Placebo Comparator group

Description:

This group was used intranasal saline, syringes were made with 4 ml of liquid 1 per patient randomized. The validity stability and were 7 days after drawing the solution.

Treatment:

Drug: Placebo