Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-12-31

Brief Summary

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The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations

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Detailed Description

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In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intravenous ketamine0.5mg/kg

intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery.

Group Type ACTIVE_COMPARATOR

Intravenous ketamine0.5mg/kg

Intervention Type DRUG

Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.

Nebulized ketamine 1mg/kg

nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia.

Group Type ACTIVE_COMPARATOR

Nebulized Ketamine 1mg/kg

Intervention Type DRUG

Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.

Nebulized ketamine 2mg/kg

nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia.

Group Type ACTIVE_COMPARATOR

Nebulized Ketamine 2mg/kg

Intervention Type DRUG

Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.

control group

control group received placebo nebulization

Group Type PLACEBO_COMPARATOR

saline placebo

Intervention Type DRUG

Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.

Interventions

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Intravenous ketamine0.5mg/kg

Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.

Intervention Type DRUG

Nebulized Ketamine 1mg/kg

Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.

Intervention Type DRUG

Nebulized Ketamine 2mg/kg

Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.

Intervention Type DRUG

saline placebo

Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.

Intervention Type DRUG

Other Intervention Names

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Katalar Katalar Katalar Saline

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study

Exclusion Criteria

* patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.

Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No