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

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Nebulized Ketamine 2mg/kg; Drug: Intravenous ketamine0.5mg/kg; Drug: Nebulized Ketamine 1mg/kg; Drug: saline placebo

• Registration Number: NCT02720406
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-25
• Study Start: 2016-04
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized ketamine 2mg/kg	Nebulized Ketamine 2mg/kg	nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia.
Intravenous ketamine0.5mg/kg	Intravenous ketamine0.5mg/kg	intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery.
Nebulized ketamine 1mg/kg	Nebulized Ketamine 1mg/kg	nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia.
control group	saline placebo	control group received placebo nebulization

Primary Outcome Measures

Name	Time	Method
Postoperative analgesic consumption	24 hours postoperative	The total amount of analgesics used in the first 24h postoperative in mg.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	24 hours postoperative	Pain intensity will be assessed postoperatively by using the Verbal Rating scale (VRS) (0 =no pain, 1 =mild pain, 2 =moderate pain, 3 =severe pain, and lastly 4 =excruciating pain). VRS assessments were performed at rest in the following time points; at arrival to PACU, 30 min, 1, 2, 3, 4, 5, 6, 12, and 24 h postoperative.; -; -; .
Ketamine serum levels to exclude systemic absorption of topical ketamine.	120 min after receiving Ketamine	the level of ketamine in the serum.

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Assiut Governorate, Egypt