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European Journal of Drug Metabolism and... Oct 2020Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND AND OBJECTIVE
Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole.
METHODS
Infants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters.
RESULTS
Seventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure.
CONCLUSIONS
A single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD.
CLINICAL TRIAL REGISTER
ClinicalTrials.gov Identifier: NCT00226044.
Topics: Administration, Oral; Administration, Rectal; Esophageal Atresia; Esophageal pH Monitoring; Female; Gastroesophageal Reflux; Hernias, Diaphragmatic, Congenital; Humans; Infant; Male; Omeprazole; Pilot Projects; Proton Pump Inhibitors; Treatment Outcome
PubMed: 32594305
DOI: 10.1007/s13318-020-00630-8 -
Cureus Feb 2024Background In pediatric dentistry, sedation aims to eliminate anxiety to facilitate the completion of dental procedures. Sedation in children is a multidimensional field...
Background In pediatric dentistry, sedation aims to eliminate anxiety to facilitate the completion of dental procedures. Sedation in children is a multidimensional field that includes the child, parents/guardians, and the health care team. The rectal route is generally painless, making it suitable for children who are afraid of needles. This route has several advantages over the oral route, including reduced patient cooperation requirements, a faster and more predictable onset, and less physical trauma than the intravenous and intramuscular routes. This case series aimed to evaluate the effectiveness and success rate of rectal sedation with ketamine and midazolam in the management of uncooperative children during dental treatment. Case presentation Ten healthy children with definitely negative behavior were enrolled in this study. Each child was given 7 mg/kg of ketamine in combination with midazolam 0.1 mg/kg by the rectal route. The mean onset sedation time was 9.5 minutes, and pulpotomy procedures were done. Behavioral response was monitored throughout treatment using the Ohio State University Behavioral Rating Scale (OSUBRS), and the depth of sedation was measured using the University of Michigan Sedation Scale (UMSS). The Houpt General Behavior Scale was used to estimate the treatment success rate based on the overall behavior rating. All 10 cases showed good anxiolysis and cooperation following rectal administration, with no side effects observed. Conclusions Rectal administration of ketamine in combination with midazolam may be considered a reliable method in the management of uncooperative children during dental treatment. No adverse effects were observed during or after the sedation procedure.
PubMed: 38529445
DOI: 10.7759/cureus.54825 -
Journal of Obstetrics and Gynaecology... Dec 2020Misoprostol is beneficial in preventing postpartum haemorrhage (PPH). However, there is no consensus yet as to which route will give the balance of efficacy, safety and...
BACKGROUND/PURPOSE
Misoprostol is beneficial in preventing postpartum haemorrhage (PPH). However, there is no consensus yet as to which route will give the balance of efficacy, safety and patient preference, especially at the recommended dose of 600 mcg. This study compared the efficacy and adverse effects of rectal and sublingual misoprostol for the prevention of PPH.
METHODS
In a prospective fashion, consenting eligible parturients were randomised into two groups to receive either 600 mcg of misoprostol rectally or sublingually after vaginal delivery. All study participants were followed up till 24 h postpartum. Primary outcomes were blood loss of 500 ml or greater and at least 10% change in peripartum haematocrit levels.
RESULTS
Seven (6.7%) and 16 (15.7%) of the sublingual and rectal routes, respectively, had PPH. However, the odds of having PPH after rectal misoprostol were at least twice the odds after the sublingual route ( = 0.041). Also, the mean blood loss after the first, fourth and 24th hour postpartum were significantly higher after rectal administration. Although significantly more patients had shivering and pyrexia after sublingual misoprostol, it was acceptable to more participants than the rectal route.
CONCLUSION
At the recommended dose, sublingually administered misoprostol ('the sweet of life') is associated with a lower incidence of PPH than the rectal route. Despite its higher incidence of shivering and pyrexia, it was accepted by more women than rectally administered misoprostol. PACTR201911500348367.
PubMed: 33417650
DOI: 10.1007/s13224-020-01338-0 -
Journal of Veterinary Internal Medicine 2014Levetiracetam is used to manage status epilepticus (SE) and cluster seizures (CS) in humans. The drug might be absorbed after rectal administration and could offer a...
BACKGROUND
Levetiracetam is used to manage status epilepticus (SE) and cluster seizures (CS) in humans. The drug might be absorbed after rectal administration and could offer a practical adjunct to rectal administration of diazepam in managing SE and CS.
HYPOTHESIS
Levetiracetam is rapidly absorbed after rectal administration in dogs and maintains target serum concentrations for at least 9 hours.
ANIMALS
Six healthy privately owned dogs between 2 and 6 years of age and weighing 10-20 kg.
METHODS
Levetiracetam (40 mg/kg) was administered rectally and blood samples were obtained immediately before (time zero) and at 10, 20, 40, 60, 90, 180, 360, and 540 minutes after drug administration. Dogs were observed for signs of adverse effects over a 24-hour period after drug administration.
RESULTS
CLEV at 10 minutes was 15.3 ± 5.5 μg/mL (mean, SD) with concentrations in the target range (5-40 μg/mL) for all dogs throughout the sampling period. Cmax (36.0 ± 10.7 μg/mL) and Tmax (103 ± 31 minutes) values were calculated and 2 disparate groups were appreciated. Dogs with feces in the rectum at the time of drug administration had lower mean Cmax values (26.7 ± 3.4 μg/mL) compared with those without (45.2 ± 4.4 μg/mL). Mild sedation was observed between 60 and 90 minutes without other adverse effects noted.
CONCLUSIONS AND CLINICAL IMPORTANCE
This study supports the use of rectally administered levetiracetam in future studies of clinical effectiveness in the management of epileptic dogs.
Topics: Administration, Rectal; Animals; Anticonvulsants; Dog Diseases; Dogs; Epilepsy; Female; Levetiracetam; Male; Piracetam
PubMed: 24417468
DOI: 10.1111/jvim.12269 -
International Journal of Colorectal... May 2024A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that... (Observational Study)
Observational Study
BACKGROUND AND AIMS
A high number of topical products are available for the treatment of hemorrhoidal symptoms. Sucralfate-based topical products constitute a new treatment alternative that act as a mechanical barrier to facilitate healing. The aim of this prospective, observational study was to determine patient- and physician-assessed effectiveness and tolerability of rectal ointment and suppositories containing sucralfate for the treatment of hemorrhoidal symptoms in routine clinical practice.
METHODS
Adult patients with diagnosed, mild-to-moderate, symptomatic non-bleeding hemorrhoids treated with rectal ointment or suppositories containing sucralfate were enrolled. Patients were administered treatment twice per day for at least 1 week until symptom resolution and/or for a maximum of 4 weeks. The primary endpoint was patient-assessed effectiveness on a modified Symptom Severity Score (mSSS, range 0 to 14). Physician-assessed effectiveness (9 symptoms, 0 to 5 Likert scale), hemorrhoid grade, and patient satisfaction were also determined.
RESULTS
Five investigators enrolled 60 patients; mean age was 48.4 ± 16.6 years and 72.4% were female. Pain or pressure sensitivity was reported as the most severe symptom by patients, and pressure sensitivity, discharge, soiling, and prolapse by physicians. Mean patient-assessed mSSS at baseline was 6.6 ± 1.9 and was significantly improved overall and in the ointment and suppository groups individually by -4.6 ± 2.0, -4.4 ± 1.8, and -4.8 ± 2.2, respectively (p < 0.0001). Investigator-assessed mean baseline symptom score was 18.1 ± 3.9 and improved by -7.1 ± 4.5, -6.9 ± 5.4, and -7.3 ± 3.5, respectively (p < 0.0001). Investigator-assessed symptoms of pressure sensitivity, swelling, and discharge were improved to the greatest extent. Hemorrhoid grade was improved in 38% of patients at the end of treatment. Compliance with treatment was 97.4% and patient satisfaction with application and onset of action was high (81.3% and 76.2%, respectively). Both the ointment and suppository were well tolerated.
CONCLUSIONS
The effectiveness of topical ointment or suppository containing sucralfate on patient- and investigator-assessed hemorrhoidal symptoms in real-life clinical practice was demonstrated. Patient satisfaction was high and treatments were well tolerated. Larger controlled trials are warranted to confirm the results.
Topics: Humans; Sucralfate; Hemorrhoids; Female; Suppositories; Male; Middle Aged; Ointments; Prospective Studies; Treatment Outcome; Patient Satisfaction; Adult; Aged; Administration, Rectal
PubMed: 38750150
DOI: 10.1007/s00384-024-04642-7 -
Medicina (Kaunas, Lithuania) 2003Recently, controlled and sustained drug delivery has become the standard in modern pharmaceutical design and an intensive research has been undertaken in achieving much... (Review)
Review
Recently, controlled and sustained drug delivery has become the standard in modern pharmaceutical design and an intensive research has been undertaken in achieving much better drug product effectiveness, reliability and safety. In this regard, many polymers are very useful with majority of hydrogels, which undergo reversible volume and/or sol-gel phase transitions in response to physiological (temperature, pH and present of ions in organism fluids, blood glucose level) or other external (electric current, light) stimuli. This article reviews the main stimuli-sensitive hydrogels and the use of these hydrogels in parenteral, ocular, peroral, rectal, vaginal, nasal, dermal and transdermal drug delivery.
Topics: Administration, Oral; Administration, Rectal; Drug Administration Routes; Drug Carriers; Drug Delivery Systems; Humans; Hydrogels; Hydrogen-Ion Concentration; Infusions, Parenteral; Polymers
PubMed: 14617853
DOI: No ID Found -
Journal of Pain and Symptom Management Apr 1990The rectal route for the administration of opioid analgesics is often forgotten by physicians seeking alternatives to the oral route. This article reviews the physiology... (Review)
Review
The rectal route for the administration of opioid analgesics is often forgotten by physicians seeking alternatives to the oral route. This article reviews the physiology of rectal drug absorption and such data as exists on the different opioids that have been administered by this route. Conventional fatty-based suppositories have a place in the management of chronic pain but the variability in dissolution and drug absorption limit their usefulness. Recently, sustained release vehicles have become available that offer the prospect of the attainment of steady analgesic drug concentrations with once or twice daily dosing. Early studies with the morphine hydrogel suppository suggest that it may be capable of fulfilling this prospect. Their inherent safety, as dose-dumping is impossible, will make them suitable for use in the home.
Topics: Administration, Rectal; Chemistry, Pharmaceutical; Humans; Narcotics
PubMed: 2189930
DOI: 10.1016/s0885-3924(05)80025-9 -
AIDS and Behavior Feb 2018Rectal douching is a common but potentially risky practice among MSM; MSM who douche may be ideal candidates for rectal microbicides as HIV prevention. Herein we...
Rectal douching is a common but potentially risky practice among MSM; MSM who douche may be ideal candidates for rectal microbicides as HIV prevention. Herein we explored rectal douching and its association with condomless receptive anal intercourse (CRAI), group sex, rates of HIV and other STIs, and likelihood to use rectal microbicide gels. We recruited a sample of 580 MSM from a geosocial-networking smartphone application in Paris, France in 2016. Regression models estimated adjusted risk ratios (aRRs) for associations between rectal douche use and (1) engagement in CRAI, (2) group sex, (3) self-reported HIV and STI diagnoses, and (4) likelihood to use rectal microbicide gels for HIV prevention. 54.3% of respondents used a rectal douche or enema in the preceding 3 months. Douching was significantly associated with CRAI (aRR: 1.77), participation in group sex (aRR: 1.42), HIV infection (aRR: 3.40), STI diagnosis (aRR: 1.73), and likelihood to use rectal microbicide gels (aRR: 1.78). Rectal douching is common among MSM, particularly those who practice CRAI, and rectal microbicide gels may be an acceptable mode of HIV prevention for MSM who use rectal douches.
Topics: Administration, Rectal; Adult; Anti-Infective Agents; Enema; France; HIV Infections; Homosexuality, Male; Humans; Male; Rectum; Risk-Taking; Sexual Behavior; Sexually Transmitted Diseases; Therapeutic Irrigation; Young Adult
PubMed: 28766026
DOI: 10.1007/s10461-017-1873-8 -
The Turkish Journal of Gastroenterology... May 2015This meta-analysis was undertaken to evaluate the effect of rectal indomethacin in the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND/AIMS
This meta-analysis was undertaken to evaluate the effect of rectal indomethacin in the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis.
MATERIALS AND METHODS
Major databases including Embase, Medline, Science Citation Index Expanded, Pubmed and the Cochrane Central Register of Controlled Trials, were searched to identify all relevant studies from January 1960 to July 2013. Randomized controlled trials (RCTs) comparing prophylactic use of rectal indomethacin versus placebo were included. Risk ratio (RR) with 95% confidence interval (CI) was calculated using fixed- or random-effect models.
RESULTS
Three studies met the inclusion criteria and were included in the final analyses. The overall incidence of post-ERCP pancreatitis (PEP) was significantly decreased by prophylactic rectal indomethacin compared with the placebo (RR=0.51; 95% CI=0.37-0.70). The pooled incidence of moderate to severe pancreatitis was also decreased by rectal indomethacin prophylaxis (RR=0.43; 95% CI=0.23-0.80).
CONCLUSION
Rectal indomethacin can reduce the overall incidence and the severity of PEP.
Topics: Administration, Rectal; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cholangiopancreatography, Endoscopic Retrograde; Female; Humans; Incidence; Indomethacin; Male; Middle Aged; Odds Ratio; Pancreatitis; Randomized Controlled Trials as Topic
PubMed: 26006198
DOI: 10.5152/tjg.2015.6000 -
BMC Gastroenterology Jul 2018Recently, although studies have investigated the role of NSAIDs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), selection of... (Meta-Analysis)
Meta-Analysis Review
What is impact of nonsteroidal anti-inflammatory drugs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a meta-analysis of randomized controlled trials.
BACKGROUND
Recently, although studies have investigated the role of NSAIDs in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), selection of the ideal drug, the time and route of its administration for the appropriate population remain controversial.
METHODS
A systematic search was done in sources including PubMed, Embase, Web of Science, the Cochrane Library Central, and ClinicalTrials.gov from from August 1, 1990 to August 1, 2017. Randomized controlled trials comparing the prophylactic use of NSAIDs versus a placebo were included. Statistical analysis was performed using the RevMan 5.3 software to assess the outcomes.
RESULTS
A total of 21 randomized controlled trials were included in the meta-analysis. Our study showed that NSAIDs significantly reduced the incidence of PEP (RR, 0.61, 95%CI,0.52-0.72; p < 0.00001). The analysis showed that indomethacin administration post-ERCP (RR, 0.47; 95% CI, 0.31-0.70; p = 0.0002) appeared to be more effective in preventing PEP than indomethacin administration pre-ERCP (RR, 0.59; 95% CI, 0.45-0.79; P = 0.0003), but there was no significant difference between the high-risk and average-risk population(p = 0.13). In the diclofenac group, it was noted that administration of diclofenac pre-ERCP (RR, 0.32; 95% CI, 0.16-0.63; p = 0.001) was more effective than that in post-ERCP (RR, 0.65; 95% CI, 0.27-1.599; p = 0.35). The relative risk of PEP was 0.63 (95% CI, 0.27-1.50; p = 0.30) in high-risk patients and 0.41 (95% CI, 0.17-0.98; p = 0.02) in average-risk patients. With regard to the route of administration, PEP decreased significantly only in patients receiving the drug rectally (RR, 0.53; 95% CI, 0.44-0.63; p < 0.00001), but not for those who received intramuscularly (RR, 0.74; 95% CI, 0.47-1.17; p = 0.20), intravenously (RR, 0.97; 95% CI, 0.51-1.83; p = 0.93), and orally (RR = 0.88; 95% CI, 0.55-0.1.43; p = 0.62).
CONCLUSIONS
Rectal administration of NSAIDs (both indomethacin and diclofenac) was effective in preventing PEP in unselected patients. A single dose of indomethacin after ERCP might be effective in preventing PEP in both high-risk and average-risk patients. However, diclofenac administered rectally before ERCP might be protective against PEP in high-risk patients compared to a placebo. However, more high quality head-to-head RCTs are required.
Topics: Administration, Rectal; Anti-Inflammatory Agents, Non-Steroidal; Cholangiopancreatography, Endoscopic Retrograde; Diclofenac; Drug Administration Routes; Drug Administration Schedule; Humans; Indomethacin; Pancreatitis; Publication Bias; Randomized Controlled Trials as Topic; Risk Factors
PubMed: 29973142
DOI: 10.1186/s12876-018-0837-4