Elective Bilateral MyringotomyNCT03742180
Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
A study testing intranasal dexmedetomidine and sublingual ketorolac in people with Elective Bilateral Myringotomy, run by Mansoura University at 1 site in Egypt.
Trial summary
The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Elective Bilateral Myringotomy
- What is being tested?
- intranasal dexmedetomidine and sublingual ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 15 May 2019
- Phase
- Interventional
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I- II.
Who cannot join
- History of ketamine
- History of NSAID
- History of allergies
- Any bleeding disorders
- History of GIT bleeding
- Those who will undergo other procedures in addition to bilateral myringotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay
Read the detailed description
Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance.
A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required
- Conditions
- Elective Bilateral Myringotomy
- Being tested
- intranasal dexmedetomidine, sublingual ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal dexmedetomidineDrug
The patient will receive intranasal dexmedetomidine in a dose of 1ug.kg-1 in a volume of 1 ml was dripped into both nostrils using a 1-mL syringe, with the patients in the recumbent position plus 1ml sublingual 0.9% saline
sublingual ketorolacDrug
The patient will receive sublingual ketorolac in a dose of 0.5 mg.kg-1 in a volume of 1 ml and 1 ml intranasal saline 0.9%
| Study group | Role | What they receive |
|---|---|---|
| intranasal dexmedetomidine | Experimental | this group is planned for intranasal dexmedetomidine Receives: Drug: intranasal dexmedetomidine |
| sublingual ketorolac | Active comparator | this group is planned for sublingual ketorolac Receives: Drug: sublingual ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of analgesia
The duration of analgesia,define as the time to the first demand for rescue analgesic
Measured: time from administering the study solution till the time for the first rescue analgesic] during first 24 hours
Secondary outcomes (6)
Postoperative pain score
Postoperative pain will be assessed by the CHEOP scale (Children's Hospital of Eastern Ontario Pain Scale) .
Measured: For 24 hours after surgery
Heart rate
Measured: for 2 hours after the start of surgery
systolic blood pressure
Measured: for 2 hours after the start of surgery
Number of patients received rescue analgesics
Total number of children who required postoperative pain medication during the 24-h period will be registered
Measured: For 24 hours after surgery
Degree of sedation
The degree of sedation will be assessed by using Ramsay scale
Measured: For 24 hours after surgery
Nausea and vomiting
Measured: For 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Jan 2018
- Primary completion30 Apr 2019
- Study completion15 May 2019
Why it stopped: Unavailable drug in Egypt.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Bilateral MyringotomyStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742180
- Sponsor's protocol ID
- R/18.06.212
- Status last verified
- Sep 2020
- First submitted
- 12 Nov 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
- ClinicalTrials.gov ID
- NCT03742180
- Acronym / sponsor ID
- R/18.06.212
- Conditions
- Elective Bilateral Myringotomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unavailable drug in Egypt.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 15 Nov 2018 (actual)
- 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 investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay
Detailed description
Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance.
A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal dexmedetomidine | Experimental | Drug: intranasal dexmedetomidinethis group is planned for intranasal dexmedetomidine |
| sublingual ketorolac | Active comparator | Drug: sublingual ketorolacthis group is planned for sublingual ketorolac |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ASA physical status I- II.
Key exclusion criteria (6 listed)
- History of ketamine
- History of NSAID
- History of allergies
- Any bleeding disorders
- History of GIT bleeding
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 |
|---|---|---|
| intranasal dexmedetomidineThe patient will receive intranasal dexmedetomidine in a dose of 1ug.kg-1 in a volume of 1 ml was dripped into both nostrils using a 1-mL syringe, with the patients in the recumbent position plus 1ml sublingual 0.9% saline | Drug | intranasal dexmedetomidine |
| sublingual ketorolacThe patient will receive sublingual ketorolac in a dose of 0.5 mg.kg-1 in a volume of 1 ml and 1 ml intranasal saline 0.9% | Drug | sublingual ketorolac |
Primary outcome
duration of analgesia
Time frame: time from administering the study solution till the time for the first rescue analgesic] during first 24 hours
The duration of analgesia,define as the time to the first demand for rescue analgesic
6 secondary outcomes
Postoperative pain score
Time frame: For 24 hours after surgery
Heart rate
Time frame: for 2 hours after the start of surgery
systolic blood pressure
Time frame: for 2 hours after the start of surgery
Number of patients received rescue analgesics
Time frame: For 24 hours after surgery
Degree of sedation
Time frame: For 24 hours after surgery
Nausea and vomiting
Time frame: For 24 hours after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intranasal dexmedetomidine and sublingual ketorolac in people with Elective Bilateral Myringotomy, run by Mansoura 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 6 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: withdrawn, as of the sponsor's last update on 9 Sep 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
duration of analgesia (time frame: time from administering the study solution till the time for the first rescue analgesic] during first 24 hours). 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 9 Sep 2020.