Effectiveness of two sedative drugs on pediatric patients during dental treatment
| ISRCTN | ISRCTN13661311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13661311 |
| Secondary identifying numbers | IRB. No. E-19-3953, CDRC No. PR 0106 |
- Submission date
- 21/11/2021
- Registration date
- 23/11/2021
- Last edited
- 15/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental anxiety and fear are frequent problems faced by dentists when dealing with young children. Moderate sedation is used to reduce anxiety and fear in patients. One of the most common sedative drugs used in the sedation of children is midazolam. Midazolam does not have any pain reducing effects, so it is often combined with another drug to reduce pain.
This study aims to evaluate the effects of combining midazolam with fentanyl in young dental patients.
Who can participate?
Children aged 3 - 6 years who require two visits involving sedation for completion of dental treatment.
What does the study involve?
The patients were randomly selected to receive either oral midazolam followed by intranasal Placebo or oral midazolam followed by intranasal fentanyl in the first visit and the other in the second visit. Each child will have two sedation visits with two different regimens. The period between the first and the second visit will be more than 2 weeks and less than 4 weeks. 24 hours after each sedation visit, a phone-call questionnaire is carried out about post-discharge adverse effects.
What are the possible benefits and risks of participating?
Possible benefits include the ability to provide dental treatment to the anxious uncooperative child in a safe and calm environment without causing psychological trauma to the child
Possible risks include postoperative transient behavioral changes such as (hallucination, disorientation, uncontrollable crying, agitation, restlessness, and aggressive behavior), dizziness, nausea, vomiting, and respiratory depression.; however, they have low prevalence and are not life-threatening
Where is the study run from?
Dental University Hospital, King Khaled Medical City, King Saud University (Saudi Arabia)
When is the study starting and how long is it expected to run for?
December 2018 to October 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Roaa Alhaidari, roaa.h@hotmail.com
Contact information
Public
Department of pediatric dentistry and orthodontics
College of dentistry
King Saud University
Riyadh
11515
Saudi Arabia
 ORCID ID |
0000-0003-2700-5488 |
|---|---|
| Phone | +966 551381409 |
| 437203478@student.ksu.edu.sa |
Study information
| Study design | Interventional randomized cross-over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Intranasal fentanyl combined with oral midazolam for pediatric dental sedation: a controlled randomized blinded cross-over clinical trial |
| Study objectives | - Children who receive intranasal fentanyl with oral midazolam will show no significant difference in sedation and behavior levels compared to those who receive oral midazolam alone. - Children who receive intranasal fentanyl with oral midazolam will show no significant difference in sedation onset time, working time, and side effects occurrence compared to those who receive oral midazolam alone. - Children who receive intranasal fentanyl with oral midazolam will show no significant difference in post discharge adverse effects compared to those who receive oral midazolam alone. - Parents/legal guardians will show no significant preference toward intranasal fentanyl with oral midazolam sedation compared to oral midazolam alone sedation. |
| Ethics approval(s) | Approved 05/09/2019, The Institutional Review Board and Ethics Committee of the College of Dentistry Research Center (King Khaled Medical City, King Saud University, Riyadh, Saudi Arabia; +966-11 469-1532; rdeocampo@ksu.edu.sa), ref: IRB. No. E-19-3953, CDRC. No. PR 0106 |
| Health condition(s) or problem(s) studied | Sedation of pediatric patients during dental treatment |
| Intervention | Children between 3 and 6 years old referred to the pediatric dental clinics at Dental University Hospital, King Khaled Medical City, King Saud University for dental treatment under moderate sedation were included in the study after confirming that they satisfy the inclusion criteria and after obtaining consent from parents/legal guardians. Children were randomly selected to receive either intranasal fentanyl (1μg/kg) or saline as placebo in the first visit and the other in the second visit along with oral midazolam (0.7mg/kg). Then, video recording was done for all sedation visits to evaluate sedation and behavior status, onset of sedation, working time, and occurrence of any side effects. Then, a questionnaire regarding post discharge adverse effects of sedation and parents/legal guardians’ satisfaction and preference was delivered 24 hours after both sedation visits through a phone call with the parents/legal guardians. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Midazolam, fentanyl |
| Primary outcome measure | 1. The sedation scores were recorded using the Modified Observer’s Alertness/ Sedation Scale (MOAA/S) after sedation at each visit 2. The behavior scores were recorded using a four-point scale (4 = combative, disoriented, or excited; 3 = moderately agitated; 2 = not calm; and 1 = calm) after sedation at each visit 3. Post-discharge adverse effects and parental satisfaction and preference were evaluated using a questionnaire 24 hours after each visit |
| Secondary outcome measures | 1. The onset of sedation was measured as the minimum time interval required for child to become drowsy after administering the oral midazolam at each visit 2. The time that elapses between the child becoming drowsy (sedation score = 4) and when the patient become alert and awake (sedation score = 5 or 6) was measured as the working time at each visit |
| Overall study start date | 11/12/2018 |
| Completion date | 22/10/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 32 |
| Total final enrolment | 32 |
| Key inclusion criteria | 1. 3 - 6 years old 2. ASA I 3. Frankl behaviour rating scale 1 or 2 4. Mallampati score I or II 5. Brodsky tonsillar size scoring 0 or 1 or 2 6. Children within the normal range of weight 7. Children who needed two sedation visits for completion of dental treatment 8. Children who needed a comparable dental treatment (as regards restorations, pulp treatment, crowns, extraction) on both sides of the same jaw. |
| Key exclusion criteria | 1. Children with learning difficulties or mental disabilities 2. Children with active upper respiratory tract infection, any history of a recent cough or cold (less than 2 weeks) 3. Children with a known allergy or hypersensitive reaction to either midazolam or fentanyl 4. Children at risk of airway obstruction 5. Children with any intranasal pathology or congenital anomaly 6. Children with a previous history of moderate sedation |
| Date of first enrolment | 26/09/2019 |
| Date of final enrolment | 22/10/2020 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
11454
Saudi Arabia
Sponsor information
University/education
Department of pediatric dentistry and orthodontics
College of dentistry
Riyadh
11545
Saudi Arabia
| Phone | +966 11 469 1531 |
|---|---|
| rdeocampo@ksu.edu.sa | |
| Website | http://ksu.edu.sa/en/ |
"ROR" |
https://ror.org/02f81g417 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 26/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (Roaa Alhaidari, e-mail: roaa.h@hotmail.com, SPSS data, the data will become available upon request, written consent from participants was obtained, no ethical or legal restrictions). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Post-discharge effects and parents' opinions | 01/02/2022 | 15/07/2022 | Yes | No |
Editorial Notes
15/07/2022: Publication reference added.
23/11/2021: Trial's existence confirmed by King Saud University.
