Effects of diazepam rectal: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Main Research Findings

Diazepam rectal gel is a widely recognized effective rescue treatment for seizure clusters in epilepsy patients. 4 Diazepam rectal gel has proven effective in treating seizure clusters, particularly in pediatric and adult patients, where it offers ease of use and high satisfaction for both patients and caregivers. 4 The routes of diazepam administration have been compared, including rectal and intranasal. 8 Intranasal administration has shown similar absorption rates and extents compared to rectal administration, making it a viable option, especially for older children and adults who often refuse rectal administration due to social objections. 8 Furthermore, intramuscular injection using an autoinjector is being explored as a route of diazepam administration. 9 Intramuscular injection with the autoinjector has demonstrated similar bioavailability compared to rectal administration. 9 These research findings suggest that diazepam rectal gel is an effective and safe option for treating seizure clusters.

Benefits and Risks

Benefit Summary

Diazepam rectal gel has shown benefits in treating seizure clusters as an effective rescue treatment, as outlined below. 4

  • Effectively suppresses seizure clusters
  • Easy to use and highly satisfactory for patients and caregivers
  • Minimal severe side effects
  • Helps reduce emergency room visits and associated costs related to seizure clusters
  • Assists in reducing stress for patients and families

Risk Summary

Diazepam rectal gel may present potential risks when treating seizure clusters, as listed below. 4

  • Drowsiness
  • Weakness
  • Dizziness
  • Dry mouth
  • Respiratory depression (rare)

Comparison of Studies

Commonalities in Studies

Multiple studies have demonstrated the effectiveness of diazepam rectal gel in treating seizure clusters. 4 9 8 Additionally, diazepam rectal gel is generally considered safe. 4 Furthermore, studies highlight the high satisfaction and ease of use of diazepam rectal gel for both patients and caregivers. 4

Differences in Studies

Research findings on the route and formulation of diazepam rectal gel have varied. 9 8 For example, comparison studies between rectal and intranasal administration have suggested that intranasal administration may provide similar absorption rates and extents. 8 Moreover, intramuscular injection using an autoinjector has shown similar drug bioavailability compared to rectal administration. 9

Consistency and Contradictions in Findings

Multiple studies consistently show the effectiveness of diazepam rectal gel in treating seizure clusters. 4 9 8 However, research findings on the route and formulation of diazepam rectal gel have varied. 9 8 Therefore, further research is needed to understand the optimal route and formulation of diazepam rectal gel for treating seizure clusters.

Application Considerations in Daily Life

Diazepam rectal gel can be applied in daily life as an effective rescue treatment for seizure clusters. 4 However, the following points should be considered when using diazepam rectal gel. 4

  • Use diazepam rectal gel as directed by your doctor
  • Consult your doctor if you experience any side effects
  • Be aware of potential interactions with other medications
  • Properly store the medication

Limitations of Current Research

Research on diazepam rectal gel has limitations, as outlined below. 4 9 8

  • Small sample sizes in some studies
  • Short follow-up periods in some studies
  • Inconsistencies in research methodologies across studies
  • Insufficient research on different routes and formulations of diazepam rectal gel

Future Research Directions

Further research is needed on diazepam rectal gel, as follows. 4 9 8

  • Conduct large-scale clinical trials with a higher number of participants
  • Implement longer follow-up periods in studies
  • Conduct research on different routes and formulations of diazepam rectal gel
  • Investigate the administration methods and dosages of diazepam rectal gel
  • Research the combined effects of diazepam rectal gel with other treatments

Conclusion

Diazepam rectal gel is considered a safe and effective rescue treatment for seizure clusters in epilepsy patients. 4 9 8 However, further research is required to understand the optimal route and formulation of diazepam rectal gel for seizure cluster management. 9 8 When using diazepam rectal gel for treating seizure clusters, it is crucial to follow your doctor's instructions and consult them if you experience any side effects. 4

Literature analysis of 19 papers
Positive Content
18
Neutral Content
1
Negative Content
0
Article Type
6
0
0
5
19
1.

Plasma-diazepam in infants after rectal administration in solution and by suppository.

Author: KnudsenF U

Acute treatment
Diazepam solution
Febrile convulsions
Side effects unknown

Diazepam was given rectally as a solution (0.7 mg/kg) or a suppository (5 mg) to 20 infants with febrile convulsions. Diazepam in solution reached anticonvulsant plasma levels within 4 +/- 1 min, while suppository administration resulted in similar levels after 20-30 min. Rectal diazepam solution may be useful in the acute treatment of febrile convulsions, while the suppository form is less effective. The study suggests that rectal diazepam solution may be suitable for home use in case of recurrent febrile convulsions, but further research is needed to evaluate its anticonvulsant effects and side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

A single-blind, crossover comparison of the pharmacokinetics and cognitive effects of a new diazepam rectal gel with intravenous diazepam.

Author: CloydJ C, LalondeR L, BeniakT E, NovackG D

Easy administration
Rapid absorption
Well tolerated
Cognitive impairment

A new rectal diazepam gel (Diastat) is rapidly absorbed and well-tolerated, with mild cognitive effects that dissipate within four hours.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

A single-blind, crossover comparison of the pharmacokinetics and cognitive effects of a new diazepam rectal gel with intravenous diazepam.

Author: CloydJ C, LalondeR L, BeniakT E, NovackG D

Easy administration
Rapid absorption
Well tolerated
Cognitive impairment

A new rectal diazepam gel (Diastat) is rapidly absorbed and well-tolerated, with mild cognitive effects that dissipate within four hours.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Treatment of Seizure Clusters in Epilepsy: A Narrative Review on Rescue Therapies.

Author: BeckerDanielle A, WhelessJames W, SirvenJoseph, TatumWilliam O, RabinowiczAdrian L, CarrazanaEnrique

Improved seizure management
Seizure cluster treatment
Mild to moderate adverse events

This review discusses the use of rescue medications for seizure clusters in epilepsy. It highlights the effectiveness of intranasal benzodiazepines, such as midazolam nasal spray and diazepam nasal spray, in treating seizure clusters and improving patient and caregiver satisfaction. The implementation of acute seizure action plans is crucial to facilitate the optimal use of rescue medications for improved seizure cluster management.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Safety of Diazepam Nasal Spray in Children and Adolescents With Epilepsy: Results From a Long-Term Phase 3 Safety Study.

Author: TarquinioDaniel, DlugosDennis, WhelessJames W, DesaiJay, CarrazanaEnrique, RabinowiczAdrian L

Safe treatment

Diazepam nasal spray demonstrated a consistent safety profile across age subgroups in patients with seizure clusters.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Intrarectal diazepam following pelvic reconstructive surgery: a double-blind, randomized placebo-controlled trial.

Author: AldrichEmily R, TamTiffanie Y, SaylorLeah M, CrispCatrina C, YeungJennifer, PaulsRachel N

Pain control

Diazepam given rectally has been shown to be effective for acute and chronic pelvic pain and is well-suited for intermittent use. However, the effectiveness of this route of administration has not been studied for postoperative pain after vaginal hysterectomy with native tissue pelvic reconstruction. The study suggests that this approach may be a promising solution for managing postoperative pain and promoting same-day discharge in these patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Safety and efficacy of diazepam autoinjector for the management of epilepsy.

Author: VerrottiAlberto, MilioniMaddalena, ZaccaraGaetano

Seizure treatment

This review discusses the use of diazepam autoinjector for the treatment of acute repetitive seizures and the need for further research.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Bioavailability of intranasal vs. rectal diazepam.

Author: IvaturiVijay, KrielRobert, BrundageRichard, LoewenGordon, MansbachHank, CloydJames

Seizure treatment
Sedation

This study compared the tolerability and pharmacokinetics of two investigational nasal formulations of diazepam (DZP) with DZP rectal gel. The study found that both intranasal formulations were well tolerated and exhibited relatively rapid, but variable, absorption.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Pharmacokinetics of diazepam administered intramuscularly by autoinjector versus rectal gel in healthy subjects: a phase I, randomized, open-label, single-dose, crossover, single-centre study.

Author: LamsonMichael J, Sitki-GreenDiane, WannarkaGerald L, MesaMichael, AndrewsPaul, PellockJohn

ARS treatment

This study evaluated the dose proportionality and bioavailability of a diazepam autoinjector compared to a rectal diazepam gel for treating acute repetitive seizures (ARS). The study aimed to assess the feasibility of a diazepam autoinjector as an alternative to rectal administration for patients with ARS.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

A comparison of midazolam nasal spray and diazepam rectal solution for the residential treatment of seizure exacerbations.

Author: de HaanGerrit-Jan, van der GeestPeter, DoelmanGerard, BertramEdward, EdelbroekPeter

Seizure suppression
Drowsiness
Local irritation

This study compared the efficacy of a novel midazolam HCl concentrated nasal spray (MDZ-n) to diazepam rectal solution (DZP-r) in treating prolonged seizures in patients with medically refractory epilepsy. Both treatments were equally effective in controlling seizures, but the nasal spray was preferred by patients and caregivers.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Effectiveness of diazepam rectal gel in adults with acute repetitive seizures and prolonged seizures: a single-center experience.

Author: FakhouryToufic, ChumleyAmber, Bensalem-OwenMeriem

Breakthrough seizures treatment
Somnolence

Diazepam rectal gel is a medication used to treat breakthrough seizures in patients with epilepsy. This study found that diazepam rectal gel was effective in stopping seizures in 90% of patients. The most common side effect was somnolence.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Emergency management of seizures in the school setting.

Author: O'DellChristine, O'HaraKathryn, KielSarah, McCulloughKathleen

Reduced ED visits
Reduced seizure time
Seizure management

This study discussed the importance of having a seizure emergency treatment plan in place for students with seizures in the school setting. Diazepam rectal gel is a safe and effective medication for treating seizures in the school setting and can be administered by medical and trained nonmedical personnel.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Safety of Diastat, a rectal gel formulation of diazepam for acute seizure treatment.

Author: PellockJohn M

Reduced abuse potential
Reduced respiratory depression
Seizure control
Sedation
Tachyphylaxis

Diazepam rectal gel (Diastat) is a medication used to treat seizures in patients with epilepsy. This study reviewed the safety of Diastat, finding it to be a safe and effective treatment option.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

New therapies in the management of acute or cluster seizures and seizure emergencies.

Author: ShaferP O

Control acute seizures
Reduced ER visits
Reduced costs
Health risks
Psychosocial stigma

New formulations and drug-delivery systems for acute repetitive seizures offer patients and health care providers greater control over seizure emergencies. Rectal diazepam has been shown to reduce emergency room visits and costs associated with emergent care.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

16.

An open-label study of repeated use of diazepam rectal gel (Diastat) for episodes of acute breakthrough seizures and clusters: safety, efficacy, and tolerance. North American Diastat Group.

Author: MitchellW G, ConryJ A, CrumrineP K, KrielR L, CereghinoJ J, GrovesL, RosenfeldW E

Effective
Safe
Agitation
Chest pain
Rash
Sedation

Diazepam rectal gel is a safe and effective treatment for acute seizures in epilepsy patients, with no significant tolerance or medication-related adverse effects seen with repeated use.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

[Discontinuous selective prophylaxis of febrile convulsions at home with rectal diazepam].

Author: DevilatM, Paz MasafierroM

Alternative to oral anticonvulsants
Treats febrile convulsions
Mild side effects

Rectal diazepam was effective in preventing febrile seizures in 15 children. The drug was associated with mild and transient side effects.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Spanish

18.

A double-blind crossover study of diazepam rectal suppositories, 5 mg and 10 mg, for sedation in patients with advanced malignant disease.

Author: EhsanullahR S, GallowayD B, GustersonF R, KingsburyA W

Sedative effect
Side effects

Diazepam suppositories were well tolerated and provided effective night-time sedation in anxious patients with terminal cancer.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

19.

Diazepam rectal solution for home treatment of acute seizures in children.

Author: HoppuK, SantavuoriP

Effective treatment
Interrupted convulsions
Dizziness
Respiratory difficulties
Skin reactions

Diazepam rectal solution was found to be effective in treating acute convulsions in children, with a good safety profile.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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