Postoperative PainPhase 2/3NCT02720406
Topical Ketamine Analgesia in Children Undergoing Tonsillectomy: a Clinical and Serum Level Assays Study.
A Phase 2/3 study testing Intravenous ketamine0.5mg/kg, Nebulized Ketamine 1mg/kg and Nebulized Ketamine 2mg/kg in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Intravenous ketamine0.5mg/kg, Nebulized Ketamine 1mg/kg and Nebulized Ketamine 2mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Ketamine by Neubulization Method in Tonsillectomy
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
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Intravenous ketamine0.5mg/kg, Nebulized Ketamine 1mg/kg, Nebulized Ketamine 2mg/kg, saline placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous ketamine0.5mg/kgDrug
Also called Katalar
Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
Nebulized Ketamine 1mg/kgDrug
Also called Katalar
Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
Nebulized Ketamine 2mg/kgDrug
Also called Katalar
Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
saline placeboDrug
Also called Saline
Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous ketamine0.5mg/kg | Active comparator | intravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery. Receives: Drug: Intravenous ketamine0.5mg/kg |
| Nebulized ketamine 1mg/kg | Active comparator | nebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia. Receives: Drug: Nebulized Ketamine 1mg/kg |
| Nebulized ketamine 2mg/kg | Active comparator | nebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia. Receives: Drug: Nebulized Ketamine 2mg/kg |
| control group | Placebo comparator | control group received placebo nebulization Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic consumption
The total amount of analgesics used in the first 24h postoperative in mg.
Measured: 24 hours postoperative
Secondary outcomes (2)
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.
-
-
.
Measured: 24 hours postoperative
Ketamine serum levels to exclude systemic absorption of topical ketamine.
the level of ketamine in the serum.
Measured: 120 min after receiving Ketamine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720406
- Sponsor's protocol ID
- AssuitUniversity
- Status last verified
- Jun 2019
- First submitted
- 22 Mar 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Ketamine by Neubulization Method in Tonsillectomy
- ClinicalTrials.gov ID
- NCT02720406
- Acronym / sponsor ID
- AssuitUniversity
- Conditions
- Postoperative Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intravenous ketamine0.5mg/kg | Active comparator | Drug: Intravenous ketamine0.5mg/kgintravenous ketamine 0.5 mg/kg given after induction of anesthesia and before surgery. |
| Nebulized ketamine 1mg/kg | Active comparator | Drug: Nebulized Ketamine 1mg/kgnebulized ketamine group received 1mg/kg ketamine by nebulzation before induction of anesthesia. |
| Nebulized ketamine 2mg/kg | Active comparator | Drug: Nebulized Ketamine 2mg/kgnebulized ketamine group received 2mg/kg ketamine by nebulzation before induction of anesthesia. |
| control group | Placebo comparator | Drug: saline placebocontrol group received placebo nebulization |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous ketamine0.5mg/kgAlso: KatalarIntravenous ketamine 0.5mg/kg after anesthesia and before surgery. | Drug | Intravenous ketamine0.5mg/kg |
| Nebulized Ketamine 1mg/kgAlso: KatalarNebulized Ketamine 1mg/kg given by nebulizer before anesthesia. | Drug | Nebulized ketamine 1mg/kg |
| Nebulized Ketamine 2mg/kgAlso: KatalarNebulized Ketamine 2mg/kg given by nebulizer before anesthesia. | Drug | Nebulized ketamine 2mg/kg |
| saline placeboAlso: SalineSaline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery. | Drug | control group |
Primary outcome
Postoperative analgesic consumption
Time frame: 24 hours postoperative
The total amount of analgesics used in the first 24h postoperative in mg.
2 secondary outcomes
Postoperative pain scores
Time frame: 24 hours postoperative
Ketamine serum levels to exclude systemic absorption of topical ketamine.
Time frame: 120 min after receiving Ketamine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous ketamine0.5mg/kg, Nebulized Ketamine 1mg/kg and Nebulized Ketamine 2mg/kg in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic consumption (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.