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

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Pain

Treatments: Drug: Nebulized Ketamine 2mg/kg; Drug: Nebulized Ketamine 1mg/kg; Drug: Intravenous ketamine0.5mg/kg; Drug: saline placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02720406

AssuitUniversity

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Intravenous ketamine0.5mg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous ketamine0.5mg/kg

Nebulized ketamine 1mg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Nebulized Ketamine 1mg/kg

Nebulized ketamine 2mg/kg

Active Comparator group

Description:

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

Treatment:

Drug: Nebulized Ketamine 2mg/kg

control group

Placebo Comparator group

Description:

control group received placebo nebulization

Treatment:

Drug: saline placebo