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

Postoperative Pain Clinical Trial

Official title:

Topical Ketamine by Neubulization Method in Tonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720406
• Other study ID #: AssuitUniversity
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Intravenous ketamine0.5mg/kg
Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
• Nebulized Ketamine 1mg/kg
Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
• Nebulized Ketamine 2mg/kg
Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
• saline placebo
Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesic consumption	The total amount of analgesics used in the first 24h postoperative in mg.	24 hours postoperative
Secondary	Postoperative pain scores	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.; -; -; .	24 hours postoperative
Secondary	Ketamine serum levels to exclude systemic absorption of topical ketamine.	the level of ketamine in the serum.	120 min after receiving Ketamine