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Completed

NCT Number: NCT02720406

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

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut university hospitals

Asyut, Assiut Governorate, Egypt,71571, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous ketamine0.5mg/kg

Drug

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

Other names: Katalar

Nebulized Ketamine 1mg/kg

Drug

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

Other names: Katalar

Nebulized Ketamine 2mg/kg

Drug

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

Other names: Katalar

Saline placebo

Drug

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

Other names: Saline

Primary outcomes

  1. Postoperative analgesic consumption

    Time frame: 24 hours postoperative

    The total amount of analgesics used in the first 24h postoperative in mg.

Secondary outcomes

  1. Postoperative pain scores

    Time frame: 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.

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    -

    .

  2. Ketamine serum levels to exclude systemic absorption of topical ketamine.

    Time frame: 120 min after receiving Ketamine

    the level of ketamine in the serum.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Topical Ketamine by Neubulization Method in Tonsillectomy

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 25, 2016
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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