Dental Caries in ChildrenPhase 4NCT04068948
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
A Phase 4 study testing Meperidine, Hydroxyzine and Midazolam in people with Dental Caries in Children and Pediatric Dental Sedation, run by University of Washington at 1 site in United States.
Trial summary
The primary objective of this randomized controlled trial is to assess the effects of oral sedation using midazolam and hydroxyzine with and without meperidine (a narcotic) on sedation outcomes in pediatric dental patients undergoing dental treatment at the University of Washington Center for Pediatric Dentistry. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Pediatric Dental Sedation, Meperidine
- What is being tested?
- Meperidine, Hydroxyzine and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2019to 31 Jan 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Are between 36-95 months of age and are planned for dental treatment at the University of Washington Center for Pediatric Dentistry,
- Are ASA I or II, (healthy, or have mild, well-controlled systemic disease)
- Are under the 95th weight for age BMI (body mass index) percentile,
- Are able to take diagnostic bitewing dental radiographs,
- Are able to take medications by mouth,
- Have Brodsky scores of II or less (tonsil sizes take up less than 50% of the oropharyngeal opening at the back of the throat),
- Are planned to receive operative treatment under local anesthesia,
- Can understand and communicate with providers in English.
Who cannot join
- Are diagnosed with autism, ADHD, or any other psychiatric or behavioral diagnosis,
- Are ASA III or higher (severe systemic disease),
- Are above the 95th weight for age BMI percentile,
- Are unable to take diagnostic radiographs,
- Will not tolerate taking medications by mouth,
- Have Brodsky scores of greater than II (tonsil sizes take up more than 50% of the oropharyngeal opening at the back of the throat),
- Have undergone oral sedation at a previous dental appointment,
- Cannot understand or communicate with providers in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Center for Pediatric Dentistry
Seattle, Washington, 98115
About this study
Official title: Comparing Pediatric Oral Sedation Outcomes Using Midazolam and Hydroxyzine With and Without Meperidine
The primary objective of this randomized controlled trial is to assess the effects of oral sedation using midazolam and hydroxyzine with and without meperidine (a narcotic) on sedation outcomes in pediatric dental patients undergoing dental treatment at the University of Washington Center for Pediatric Dentistry. Procedural sedation can be offered as an option for dental treatment for a young, potentially uncooperative pediatric patient to safely and effectively complete dental restorative needs. Both sedation regimens are already regularly used for patients at the UW CPD. The goal of this study is to assess if removing a narcotic from the regimen will produce the same behavioral success outcomes as a regimen with a narcotic. Our hypothesis is that patients who receive oral sedation using midazolam, hydroxyzine, and meperidine will experience fewer behavioral failures than those who receive oral sedation using midazolam and hydroxyzine without meperidine.
The secondary objective of this project is to evaluate the relationship between child temperament and sedation outcome in each treatment group.
Read the detailed description
Young children in the dental setting can pose significant behavioral challenges. These patients may have dental anxiety or lack the effortful control (self-regulation) to successfully navigate the dental experience. Oral procedural sedation is an advanced pharmacological behavior guidance technique that can be used as part of the pediatric dentist's armamentarium when basic behavior guidance techniques are likely to be ineffective. Oral sedation can be a valuable tool, not only to facilitate dental treatment, but also to protect a young child's psyche, reduce dental fear, and ensure safety of both the patient and the dental team.
Case selection is crucial to optimizing sedation outcomes. In addition to biological factors like age, gender, and weight, temperament must also be carefully evaluated for the pediatric oral sedation candidate. Compared with children with high levels of effortful control, children who exhibit high levels of impulsivity may be more likely to respond poorly to uncomfortable or unfamiliar procedures, exhibit uncooperative behavior during sedation, and ultimately experience more sedation failures.
There is no standard drug regimen or protocol for oral sedation. Medications used for sedation studies often have a wide therapeutic range, and dosages used in the literature vary widely. Varying drug regimens can also be used depending on operator preference and the extent of the procedure. Benzodiazepines, opioids, and antihistamines are commonly used drug options that can be used alone or in combination to achieve desired sedative effects and minimize potential side effects of counterpart drugs. For example, midazolam is a rapid-onset, short acting benzodiazepine that offers a sedative effect with some degree of amnesia. These qualities make midazolam an ideal sedative for relatively minor or quick operative procedures in young children. An opioid such as meperidine can be added to potentiate the sedative effect and offer analgesia for lengthier, more complex procedures. Additionally, an antihistamine like hydroxyzine can be added for additional sedative effects as well as an antiemetic effect to counter potential nausea from the use of an opioid. The use of supplemental nitrous oxide/oxygen (N2O/O2) in conjunction with a chosen sedation regimen has been shown to further potentiate sedation effects and improve sedation outcomes.
Despite proving to be an effective behavior management technique, procedural sedation poses its own set of risks. Compared with intravenous or intranasal methods of drug delivery, oral delivery of sedation medications can be challenging due to longer and more variable onset to sedation, unpredictable hepatic first-pass absorption and bioavailability, and an inability to titrate the medications. Sedation effects may linger long after the procedure is completed and affect post-discharge outcomes. Additionally, the use of multiple medications has been shown to increase the risk of adverse outcomes compared with single or dual-combination drug regimens.
The majority of adverse events during sedation can be avoided with careful case selection, medication dosing, and proper intra-operative monitoring. When adverse events do occur, they are typically due to respiratory depression, and can include laryngospasm, neurologic injury, and death. Thus, to avoid oversedation and subsequent adverse sequelae, multi-drug regimens (especially those that contain opioids like meperidine) must be used judiciously.
The midazolam/meperidine/hydroxyzine regimen is a popular combination of medications for pediatric dental sedation. The increase in the use of meperidine has been associated with a movement away from utilization of chloral hydrate (another sedative with no reversal agent, previously frequently used in conjunction with a combination of the aforementioned drugs or other drugs). While there are studies comparing sedation regimens that include both chloral hydrate and meperidine used together, meperidine is an increasingly preferred option over chloral hydrate for procedural sedation, especially with the availability of a reversal agent for the opioid in the instance of oversedation, as well as a shorter half-life compared with chloral hydrate. While narcotic-containing regimens are popular, there are still inherent risks in utilization of an opioid in any sedation regimen. Several studies have been published comparing sedation regimens that include meperidine, but to date, there are no studies comparing the efficacy of midazolam and hydroxyzine with and without meperidine. Additionally, many studies compare side effects of different regimens (for example, post-operative drowsiness, nausea, time spent asleep, crying), but few utilize the Houpt Behavior Rating that we plan to use to categorize sedation outcomes.
- Being tested
- Meperidine, Hydroxyzine, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeperidineDrug
This intervention assesses a child's behavioral outcome for dental procedural sedation in combination with midazolam and hydroxyzine. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
HydroxyzineDrug
This intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
MidazolamDrug
This intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
| Study group | Role | What they receive |
|---|---|---|
| Midazolam, Hydroxyzine, Meperidine | Active comparator | Participants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure. Receives: Drug: Meperidine; Drug: Hydroxyzine; Drug: Midazolam |
| Midazolam, Hydroxyzine | Experimental | Participants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure. Receives: Drug: Hydroxyzine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Sedation
Children's behavior during sedation is rated on the Houpt Behavior Rating Scale. A successful sedation is rated as Excellent, Very Good, or Good. A failed sedation is rated as Fair, Poor, or Aborted.
Measured: At completion of procedure
Secondary outcomes (1)
Child Temperament According to CBQ-SF and Association With Sedation Outcomes
Children's temperament will be assessed via parental completion of the Child Behavior Questionnaire Short Form (CBQ-SF) to assess which child temperaments may be more suitable candidates for dental oral sedation.
The CBQ-SF is a set of 94 statements scoring a child's temperament on 15 domains: activity level, anger/frustration, approach/positive anticipation, attentional focusing, discomfort, falling reactivity/soothability, fear, high intensity pleasure, impulsivity, inhibitory control, low intensity pleasure, perceptual sensitivity, sadness, shyness, and smiling and laughter.
There is no "better or worse outcome." The range is from 1 (minimum) to 7 (maximum) for all domains. A higher score indicates closer alignment with that temperament domain.
Subscales of each primary domain (Effortful Control, Negative Affectivity, and Extraversion/Surgency) are combined and the sums averaged to create the total score for the 3 primary domains
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Jun 2019
- Primary completion31 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized clinical trial where participants are assigned randomly to receive a sedation regimen of either midazolam+hydroxyzine+meperidine or midazolam+hydroxyzine.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Travis Nelson, University of Washington
- Investigators
- Travis M Nelson, DDS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068948
- Sponsor's protocol ID
- STUDY00006758
- Status last verified
- Dec 2023
- First submitted
- 22 Aug 2019
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashley PF, Chaudhary M, Lourenco-Matharu L. Sedation of children undergoing dental treatment. Cochrane Database Syst Rev. 2018 Dec 17;12(12):CD003877. doi: 10.1002/14651858.CD003877.pub5.
PubMed 30566228Attri JP, Sharan R, Makkar V, Gupta KK, Khetarpal R, Kataria AP. Conscious Sedation: Emerging Trends in Pediatric Dentistry. Anesth Essays Res. 2017 Apr-Jun;11(2):277-281. doi: 10.4103/0259-1162.171458.
PubMed 28663606Chicka MC, Dembo JB, Mathu-Muju KR, Nash DA, Bush HM. Adverse events during pediatric dental anesthesia and sedation: a review of closed malpractice insurance claims. Pediatr Dent. 2012 May-Jun;34(3):231-8.
PubMed 22795157Chowdhury J, Vargas KG. Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients. Pediatr Dent. 2005 May-Jun;27(3):191-7.
PubMed 16173222Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.
PubMed 10742324Gentz R, Casamassimo P, Amini H, Claman D, Smiley M. Safety and Efficacy of 3 Pediatric Midazolam Moderate Sedation Regimens. Anesth Prog. 2017 Summer;64(2):66-72. doi: 10.2344/anpr-64-02-04.
PubMed 28604093Kain ZN, MacLaren J, McClain BC, Saadat H, Wang SM, Mayes LC, Anderson GM. Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology. 2007 Oct;107(4):545-52. doi: 10.1097/01.anes.0000281895.81168.c3.
PubMed 17893449Lane KJ, Nelson TM, Thikkurissy S, Scott JM. Assessing Temperament as a Predictor of Oral Sedation Success Using the Children's Behavior Questionnaire Short Form. Pediatr Dent. 2015 Sep-Oct;37(5):429-35.
PubMed 26531085McKee KC, Nazif MM, Jackson DL, Barnhart DC, Close J, Moore PA. Dose-responsive characteristics of meperidine sedation in preschool children. Pediatr Dent. 1990 Jul-Aug;12(4):222-7.
PubMed 2077497McCormack L, Chen JW, Trapp L, Job A. A comparison of sedation-related events for two multiagent oral sedation regimens in pediatric dental patients. Pediatr Dent. 2014 Jul-Aug;36(4):302-8.
PubMed 25197995Shapira J, Kupietzky A, Kadari A, Fuks AB, Holan G. Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients. Pediatr Dent. 2004 Nov-Dec;26(6):492-6.
PubMed 15646910
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pediatric Oral Sedation Outcomes Using Midazolam and Hydroxyzine With and Without Meperidine
- ClinicalTrials.gov ID
- NCT04068948
- Acronym / sponsor ID
- STUDY00006758
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this randomized controlled trial is to assess the effects of oral sedation using midazolam and hydroxyzine with and without meperidine (a narcotic) on sedation outcomes in pediatric dental patients undergoing dental treatment at the University of Washington Center for Pediatric Dentistry. Procedural sedation can be offered as an option for dental treatment for a young, potentially uncooperative pediatric patient to safely and effectively complete dental restorative needs. Both sedation regimens are already regularly used for patients at the UW CPD. The goal of this study is to assess if removing a narcotic from the regimen will produce the same behavioral success outcomes as a regimen with a narcotic. Our hypothesis is that patients who receive oral sedation using midazolam, hydroxyzine, and meperidine will experience fewer behavioral failures than those who receive oral sedation using midazolam and hydroxyzine without meperidine.
The secondary objective of this project is to evaluate the relationship between child temperament and sedation outcome in each treatment group.
Detailed description
Young children in the dental setting can pose significant behavioral challenges. These patients may have dental anxiety or lack the effortful control (self-regulation) to successfully navigate the dental experience. Oral procedural sedation is an advanced pharmacological behavior guidance technique that can be used as part of the pediatric dentist's armamentarium when basic behavior guidance techniques are likely to be ineffective. Oral sedation can be a valuable tool, not only to facilitate dental treatment, but also to protect a young child's psyche, reduce dental fear, and ensure safety of both the patient and the dental team.
Case selection is crucial to optimizing sedation outcomes. In addition to biological factors like age, gender, and weight, temperament must also be carefully evaluated for the pediatric oral sedation candidate. Compared with children with high levels of effortful control, children who exhibit high levels of impulsivity may be more likely to respond poorly to uncomfortable or unfamiliar procedures, exhibit uncooperative behavior during sedation, and ultimately experience more sedation failures.
There is no standard drug regimen or protocol for oral sedation. Medications used for sedation studies often have a wide therapeutic range, and dosages used in the literature vary widely. Varying drug regimens can also be used depending on operator preference and the extent of the procedure. Benzodiazepines, opioids, and antihistamines are commonly used drug options that can be used alone or in combination to achieve desired sedative effects and minimize potential side effects of counterpart drugs. For example, midazolam is a rapid-onset, short acting benzodiazepine that offers a sedative effect with some degree of amnesia. These qualities make midazolam an ideal sedative for relatively minor or quick operative procedures in young children. An opioid such as meperidine can be added to potentiate the sedative effect and offer analgesia for lengthier, more complex procedures. Additionally, an antihistamine like hydroxyzine can be added for additional sedative effects as well as an antiemetic effect to counter potential nausea from the use of an opioid. The use of supplemental nitrous oxide/oxygen (N2O/O2) in conjunction with a chosen sedation regimen has been shown to further potentiate sedation effects and improve sedation outcomes.
Despite proving to be an effective behavior management technique, procedural sedation poses its own set of risks. Compared with intravenous or intranasal methods of drug delivery, oral delivery of sedation medications can be challenging due to longer and more variable onset to sedation, unpredictable hepatic first-pass absorption and bioavailability, and an inability to titrate the medications. Sedation effects may linger long after the procedure is completed and affect post-discharge outcomes. Additionally, the use of multiple medications has been shown to increase the risk of adverse outcomes compared with single or dual-combination drug regimens.
The majority of adverse events during sedation can be avoided with careful case selection, medication dosing, and proper intra-operative monitoring. When adverse events do occur, they are typically due to respiratory depression, and can include laryngospasm, neurologic injury, and death. Thus, to avoid oversedation and subsequent adverse sequelae, multi-drug regimens (especially those that contain opioids like meperidine) must be used judiciously.
The midazolam/meperidine/hydroxyzine regimen is a popular combination of medications for pediatric dental sedation. The increase in the use of meperidine has been associated with a movement away from utilization of chloral hydrate (another sedative with no reversal agent, previously frequently used in conjunction with a combination of the aforementioned drugs or other drugs). While there are studies comparing sedation regimens that include both chloral hydrate and meperidine used together, meperidine is an increasingly preferred option over chloral hydrate for procedural sedation, especially with the availability of a reversal agent for the opioid in the instance of oversedation, as well as a shorter half-life compared with chloral hydrate. While narcotic-containing regimens are popular, there are still inherent risks in utilization of an opioid in any sedation regimen. Several studies have been published comparing sedation regimens that include meperidine, but to date, there are no studies comparing the efficacy of midazolam and hydroxyzine with and without meperidine. Additionally, many studies compare side effects of different regimens (for example, post-operative drowsiness, nausea, time spent asleep, crying), but few utilize the Houpt Behavior Rating that we plan to use to categorize sedation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial where participants are assigned randomly to receive a sedation regimen of either midazolam+hydroxyzine+meperidine or midazolam+hydroxyzine.
| Arm | Type | Receives |
|---|---|---|
| Midazolam, Hydroxyzine, Meperidine | Active comparator | Drug: Meperidine, Drug: Hydroxyzine, Drug: MidazolamParticipants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure. |
| Midazolam, Hydroxyzine | Experimental | Drug: Hydroxyzine, Drug: MidazolamParticipants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Are between 36-95 months of age and are planned for dental treatment at the University of Washington Center for Pediatric Dentistry,
- Are ASA I or II, (healthy, or have mild, well-controlled systemic disease)
- Are under the 95th weight for age BMI (body mass index) percentile,
- Are able to take diagnostic bitewing dental radiographs,
- Are able to take medications by mouth,
Key exclusion criteria (8 listed)
- Are diagnosed with autism, ADHD, or any other psychiatric or behavioral diagnosis,
- Are ASA III or higher (severe systemic disease),
- Are above the 95th weight for age BMI percentile,
- Are unable to take diagnostic radiographs,
- Will not tolerate taking medications by mouth,
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 |
|---|---|---|
| MeperidineThis intervention assesses a child's behavioral outcome for dental procedural sedation in combination with midazolam and hydroxyzine. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine. | Drug | Midazolam, Hydroxyzine, Meperidine |
| HydroxyzineThis intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine. | Drug | Midazolam, Hydroxyzine, Midazolam, Hydroxyzine, Meperidine |
| MidazolamThis intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine. | Drug | Midazolam, Hydroxyzine, Midazolam, Hydroxyzine, Meperidine |
Primary outcome
Number of Participants With Successful Sedation
Time frame: At completion of procedure
Children's behavior during sedation is rated on the Houpt Behavior Rating Scale. A successful sedation is rated as Excellent, Very Good, or Good. A failed sedation is rated as Fair, Poor, or Aborted.
1 secondary outcome
Child Temperament According to CBQ-SF and Association With Sedation Outcomes
Time frame: During procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30566228Ashley PF, Chaudhary M, Lourenco-Matharu L. Sedation of children undergoing dental treatment. Cochrane Database Syst Rev. 2018 Dec 17;12(12):CD003877. doi: 10.1002/14651858.CD003877.pub5.
- Background: PubMed 28663606Attri JP, Sharan R, Makkar V, Gupta KK, Khetarpal R, Kataria AP. Conscious Sedation: Emerging Trends in Pediatric Dentistry. Anesth Essays Res. 2017 Apr-Jun;11(2):277-281. doi: 10.4103/0259-1162.171458.
- Background: PubMed 22795157Chicka MC, Dembo JB, Mathu-Muju KR, Nash DA, Bush HM. Adverse events during pediatric dental anesthesia and sedation: a review of closed malpractice insurance claims. Pediatr Dent. 2012 May-Jun;34(3):231-8.
- Background: PubMed 16173222Chowdhury J, Vargas KG. Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients. Pediatr Dent. 2005 May-Jun;27(3):191-7.
- Background: PubMed 10742324Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.
- Background: PubMed 28604093Gentz R, Casamassimo P, Amini H, Claman D, Smiley M. Safety and Efficacy of 3 Pediatric Midazolam Moderate Sedation Regimens. Anesth Prog. 2017 Summer;64(2):66-72. doi: 10.2344/anpr-64-02-04.
- Background: PubMed 17893449Kain ZN, MacLaren J, McClain BC, Saadat H, Wang SM, Mayes LC, Anderson GM. Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology. 2007 Oct;107(4):545-52. doi: 10.1097/01.anes.0000281895.81168.c3.
- Background: PubMed 26531085Lane KJ, Nelson TM, Thikkurissy S, Scott JM. Assessing Temperament as a Predictor of Oral Sedation Success Using the Children's Behavior Questionnaire Short Form. Pediatr Dent. 2015 Sep-Oct;37(5):429-35.
- Background: PubMed 2077497McKee KC, Nazif MM, Jackson DL, Barnhart DC, Close J, Moore PA. Dose-responsive characteristics of meperidine sedation in preschool children. Pediatr Dent. 1990 Jul-Aug;12(4):222-7.
- Background: PubMed 25197995McCormack L, Chen JW, Trapp L, Job A. A comparison of sedation-related events for two multiagent oral sedation regimens in pediatric dental patients. Pediatr Dent. 2014 Jul-Aug;36(4):302-8.
- Background: PubMed 15646910Shapira J, Kupietzky A, Kadari A, Fuks AB, Holan G. Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients. Pediatr Dent. 2004 Nov-Dec;26(6):492-6.
- 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.
Travis M Nelson, DDS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meperidine, Hydroxyzine and Midazolam in people with Dental Caries in Children and Pediatric Dental Sedation, run by University of Washington at 1 site in United States.
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 8 inclusion and 8 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 24 Jan 2024. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Successful Sedation (time frame: At completion of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068948, which also lists 11 linked publications.
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 24 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.