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Results for “Randomized controlled trials”

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PubMed2005

International collaboration, funding and association with burden of disease in randomized controlled trials in Africa.

OBJECTIVE: This study aimed to assess whether randomized controlled trials conducted in Africa with collaborators from outside Africa were more closely associated with health conditions that have a burden of disease that is of specific importance to Africa than with conditions of more general global importance or with conditions important to developed countries. We also assessed whether the source of funding influenced a study's relevance to Africa. METHODS: We compared randomized controlled trials performed in Africa that looked at diseases specifically relevant to Africa (as determined by burden of disease criteria) with trials classified as looking at diseases of global importance or diseases important to developed countries in order to assess differences in collaboration and funding. FINDINGS: Of 520 trials assessed, 347 studied diseases that are specifically important to Africa; 99 studied globally important diseases and 74 studied diseases that are important to developed countries. The strongest independent predictor of whether a study was of specifically African or global importance was the corresponding author's country of origin: African importance was negatively associated with a corresponding author being from South Africa (odds ratio (OR) = 0.04; 95% confidence interval (CI) = 0.02-0.10) but there was little difference between corresponding authors from other African countries and corresponding authors from countries outside Africa. The importance of a study to Africa was independently associated with having more non-African authors (OR per author = 1.31; 95% CI = 1.08-1.58), fewer trial sites (OR per site = 0.69; 95% CI = 0.50-0.96), and reporting of funding (OR = 2.14; 95% CI = 1.15-4.00). Similar patterns were present in the comparisons of trials studying diseases important to Africa versus those studying diseases important to developed countries with stronger associations overall. When funding was reported, private industry funding was negatively associated with African importance compared with global importance (OR = 0.31, P= 0.008 for African importance and OR = 0.51, P= 0.57 for importance for developed countries). CONCLUSION: The relevance to Africa of trials conducted in Africa was not adversely affected by collaboration with non-African researchers but funding from private industry was associated with a decreased emphasis on diseases relevant to Africa.

Africa↗

PubMed1996

Doing randomized controlled trials in a developing country: some practical realities.

BACKGROUND: Formal randomized controlled trial results are often reported. The difficulties of doing such trial are not. Developing countries represent a new field in which trials can be undertaken. In this context even less is known about the practicalities involved. METHOD AND RESULTS: A randomized, double-blind, parallel study took significantly longer than expected to complete and subject recruitment and participation fell short of expectations. Different recruitment strategies were used and these performed differently in terms of enrolling trialists. Subjects most frequently left the trial in its early stages. CONCLUSIONS: Possible explanations for these findings include the demography of the country, cultural factors, and the existence of an established doctor-patient relationship.

Antihypertensive Agents↗

PubMed1996

Morbidity outcome in early versus conventional tracheal extubation after coronary artery bypass grafting: a prospective randomized controlled trial.

INTRODUCTION: We undertook a prospective, randomized, controlled clinical trial to evaluate morbidity outcomes and safety of a modified anesthetic technique to provide shorter sedation and early extubation (1 to 6 hours) than those of the conventional anesthetic protocol used for prolonged sedation and extubation (12 to 22 hours) in patients after coronary artery bypass grafting. METHODS: One hundred twenty patients undergoing elective coronary artery bypass grafting were prospectively assigned randomly to either an early extubation group (n = 60; 15 micrograms.kg-1 fentanyl and 2 to 6 mg.kg-1.hour-1 propofol and isoflurane) or to a conventional extubation group (n = 60; 50 micrograms.kg-1 fentanyl and 0.1 mg.kg-1 midazolam and isoflurane). Cardiac morbidity (postoperative myocardial ischemia, postoperative myocardial infarction, and perioperative sympathoadrenal stress response), respiratory morbidity (postextubation apnea, alveolar-arterial oxygen gradient, pulmonary shunting, oxygen consumption, atelectasis, and reintubation), hemodynamic values and vasoactive medication requirements, intraoperative awareness, postoperative cognitive function, 30 day mortality, and intensive care unit and hospital lengths of stay were compared between the two groups. RESULTS: Fifty-one of the 60 patients in each group (85%) were extubated within the defined time period. Postoperative extubation time and intensive care unit and hospital lengths of stay were significantly shorter in the early group. At 48 hours after operation, there were no significant differences between the two groups in myocardial ischemia incidences, ischemia burdens, or creatine kinase isoenzyme MB levels. Four patients in the conventional group, but not in the early group, had postoperative myocardial infaction. The extubation anesthetics used were effective in suppressing the perioperative plasma catecholamine stress response in both groups. Postextubation apnea characteristics were similar between the groups. Intrapulmonary shunt fraction improved significantly in the early group at 4 hours after extubation. The incidences and degree of atelectasis did not differ significantly between the two groups. The incidences of treated postoperative complications were comparable between the two groups, but three patients in the conventional group died as a result of stroke or postoperative myocardial infarction. CONCLUSION: Early extubation after coronary artery bypass grafting is safe and does not increase perioperative morbidity. There is an improvement in postextubation intrapulmonary shunt fraction and a reduction in intensive care unit and hospital lengths of stay.

Aged↗

PubMed1999

Acupuncture for low back pain: results of a pilot study for a randomized controlled trial.

OBJECTIVES: To pilot procedures to be used in a randomized controlled trial of acupuncture for low back pain. DESIGN: Uncontrolled clinical trial. SETTING: Primary care and acupuncture clinics in York, England. SUBJECTS: 20 patients with low back pain lasting 1 month or more. INTERVENTIONS: 10 sessions of individualized acupuncture from a traditional acupuncturist. MAIN OUTCOME MEASURES: Change in Oswestry low back pain disability questionnaire; present pain intensity scale; effect on daily living scale, and SF-36 general health questionnaire at post-treatment and 6 months after the end of treatment. RESULTS: 14 patients completed follow-up. Patients had similar severity scores at baseline to those referred to an NHS outpatient clinic. Post-treatment, there were statistically significant improvements in Oswestry, present pain intensity, effect on daily living and the physical functioning, social functioning, bodily pain, vitality and mental health sub-scales of the SF36. Similar results were found at the six month follow-up. Oswestry scores showed reduced levels of pain at 6 months compared to than at post-treatment, falling approximately 40% from baseline. CONCLUSIONS: Though the improvements in pain and quality in life may be due to the natural course of back pain, the promising responses justify further research. The procedures used in the study are appropriate for a randomized controlled trial. Drop-out could be reduced by more careful patient monitoring.

Activities of Daily Living↗

PubMed1997

Effects of beta-blocker therapy on mortality in patients with heart failure. A systematic overview of randomized controlled trials.

AIMS: Several randomized trials have reported that beta-blocker therapy improves left ventricular function and reduces the rate of hospitalization in patients with congestive heart failure. However, most trials were individually too small to assess reliably the effects of treatment on mortality. In these circumstances a systematic overview of all trials of beta-blocker therapy in patients with congestive heart failure may provide the most reliable guide to treatment effects. METHODS AND RESULTS: Details were sought from all completed randomized trials of oral beta-blocker therapy in patients with heart failure of any aetiology. In particular, data on mortality were sought from all randomized patients for the scheduled treatment period. The typical effect of treatment on mortality was estimated from an overview in which the results of all individual trials were combined using standard statistical methods. Twenty-four randomized trials, involving 3141 patients with stable congestive heart failure were identified. Complete data on mortality were obtained from all studies, and a total of 297 deaths were documented during an average of 13 months of follow-up. Overall, there was a 31% reduction in the odds of death among patients assigned a beta-blocker (95% confidence interval 11 to 46%, 2P = 0.0035), representing an absolute reduction in mean annual mortality from 9.7% to 7.5%. The effects on mortality of vasodilating beta-blockers (47% reduction SD 15), principally carvedilol, were non-significantly greater (2P = 0.09) than those of standard agents (18% reduction SD 15), principally metoprolol. CONCLUSIONS: Beta-blocker therapy is likely to reduce mortality in patients with heart failure. However, large-scale, long-term randomized trials are still required to confirm and quantify more precisely the benefit suggested by this overview.

Administration, Oral↗

PubMed2002

The timing of intravenous crystalloid administration and incidence of cardiovascular side effects during spinal anesthesia: the results from a randomized controlled trial.

UNLABELLED: We conducted a randomized clinical trial to evaluate the efficacy of crystalloids in preventing spinal-induced hypotension (SIH) and cardiovascular side effects (CVSE) in a group of surgical patients. Participants were assigned to receive lactated Ringer's solution at 1-2 mL/min (Placebo group, n = 142); lactated Ringer's at 20 mL/kg starting 20 min before spinal block (n = 130); or lactated Ringer's at 20 mL/kg starting at the time of spinal block (n = 132). SIH was defined as a decrease of > or = 30% in baseline systolic blood pressure, and CVSE as SIH plus nausea, vomiting, or faintness requiring treatment. The incidence of SIH was similar in all treatment groups. Compared to placebo, crystalloid administration at the time of spinal block resulted in a significant reduction in the proportion of patients developing CVSE from 9.9% to 2.3%. The corresponding relative proportion was 0.23 (95% confidence interval, 0.07-0.78; P = 0.019), and one additional case of CVSE was avoided for each 13 patients receiving crystalloids at the time of spinal block instead of placebo. Administration of crystalloids at the time of spinal block seems to be effective because it provides additional intravascular fluids during the period of highest risk of CVSE after spinal anesthesia. IMPLICATIONS: Crystalloids are frequently administered to nonobstetric patients minutes before spinal anesthesia to prevent cardiovascular side effects (CVSE). This randomized controlled trial shows that although crystalloids administered before spinal block result in no clinical benefit, they significantly reduce the risk of CVSE when administered at the time of spinal block.

Adolescent↗

PubMed2005

Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials.

Two multicenter, randomized, double-blind, crossover studies with identical designs evaluated the efficacy of oral extended-release hydromorphone (HHER) administered q24h compared with immediate-release hydromorphone (HHIR) dosed four times daily in patients with persistent moderate to severe pain. Patients titrated to a stable HHER dose were randomized to individualized doses of HHER or HHIR for 3 to 7 days before crossover to the second treatment. Primary efficacy end point was the mean of average pain intensity (API) scores, rated on a 0- to 10-point numeric scale, over the last 2 days before the pharmacokinetics/pharmacodynamics day of each double-blind period. Difference between treatments (HHER - HHIR) in study 1 was 0.17 with a 90% confidence interval (CI) (-0.01, 0.34); in study 2, difference was 0.07 with a 90% CI (-0.12, 0.26). There were no significant differences between treatments in API scores or amount of rescue medication used at any time interval within the 24-hour dosing period. No reduction in pain control occurred in patients administered HHER at the end of the 24-hour dosing period. Most treatment-emergent adverse events were opioid-related. In these studies, HHER administered q24h and HHIR dosed four times daily provided comparable analgesia at an equivalent total daily dose.

Administration, Oral↗

PubMed2006

Systematic review: evidence-based management of hepatocellular carcinoma--an updated analysis of randomized controlled trials.

The treatment strategy of hepatocellular carcinoma applied following scientific guidelines is only supported by 77 randomized controlled trials published so far, a figure that clearly pinpoints hepatocellular carcinoma as an 'orphan' cancer in terms of clinical research when compared with other high-prevalent cancers worldwide. A systematic review analysing 61 randomized controlled trials (1978-2002) showed a modest survival benefit from chemoembolization in patients with intermediate tumours, and the lack of an effective first-line treatment option for patients with advanced disease. These conclusions have been endorsed by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. The present updated evidence-based approach includes 16 randomized controlled trials published from 2002 to 2005 assessing percutaneous ablation (seven), other loco-regional therapies (three) and systemic therapies (six). Eight showed high-quality methodological profiles. Four randomized controlled trials demonstrated a better local hepatocellular carcinoma control in tumours larger than 2 cm treated by radiofrequency ablation compared with ethanol injection. No survival advantages were obtained from systemic treatments in patients with advanced hepatocellular carcinoma, an area that is an unmet need. Therefore, there is an urgent request to conduct well-designed phase III investigations in hepatocellular carcinoma patients.

Carcinoma, Hepatocellular↗

PubMed1991

Recombinant human alpha-interferon in patients with chronic non-A, non-B hepatitis: a multicenter randomized controlled trial from France.

We have conducted a multicenter randomized controlled trial comparing two doses of recombinant human alpha-interferon for efficacy in 60 patients with chronic non-A, non-B hepatitis. The source of infection appeared to be transfusion in 30 patients, intravenous drug abuse in 16 patients and was unknown in 14 patients. Patients were randomly assigned to no treatment or to treatment with either 1 or 3 MU of alpha-interferon given three times a week for 24 wk. Forty-five patients (75%) were positive for antibody to hepatitis C virus. During the 24-wk treatment period, mean serum ALT levels decreased in both treatment groups, but the decrease was statistically significant only in the 3 MU group. However, at 24 wk, the proportion of patients with normal ALT levels was similar in the 3 MU group (39%) and the 1 MU group (45%), and both were significantly higher than in controls (0%). Repeat liver biopsy specimens showed a significant decrease in the severity of histological changes in the 3 MU group but not in the 1 MU group or in controls. Responses to alpha-interferon did not correlate with patient's age, gender, source of infection, pretreatment serum ALT, presence of anti-hepatitis C virus or cirrhosis. After treatment, the mean ALT levels rose in both treated groups. The proportion of patients with normal ALT levels at wk 48 was 28% in the 3 MU group and 20% in the 1 MU group. In conclusion, a dose of 3 MU was superior to 1 MU of alpha-interferon given three times weekly for 24 wk in inducing improvements in serum ALT levels and liver histological examinations.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

PubMed2003

Interferon beta-1a in primary progressive MS: an exploratory, randomized, controlled trial.

BACKGROUND: Patients with primary progressive MS have atypical clinical and MRI characteristics and have been excluded from most therapeutic trials. The authors report a randomized, controlled trial restricted to primary progressive MS. METHODS: Fifty subjects were randomized to weekly IM interferon beta-1a 30 microg, 60 microg, or placebo for 2 years. The primary endpoint was time to sustained progression in disability. Secondary outcomes included the timed 10-meter walk, nine-hole peg test, and on MRI, T2 and T1 brain lesion loads and brain and spinal cord atrophy. RESULTS: The 30- microg dose of interferon beta-1a was well tolerated, but the 60- microg dose caused severe flulike reactions and raised liver enzymes. No treatment effect was seen on the primary endpoint. Subjects on interferon beta-1a 30 microg had a lower rate of accumulation of T2 lesion load than controls (p = 0.025); subjects on 60 microg had a greater rate of ventricular enlargement than controls (p = 0.025). CONCLUSIONS: This study has demonstrated that interferon beta-1a 30 microg was well tolerated, identified useful outcome measures, but showed no efficacy on the primary outcome measure or on most of the secondary outcome measures.

Adult↗

PubMed2003

Hormonal contraception during lactation. systematic review of randomized controlled trials.

Contraception choices may be limited for lactating women due to concerns about hormonal effects on quality and quantity of milk, passage of hormones to the infant and infant growth. We conducted a systematic review of randomized controlled trials to determine the effect of hormonal contraception on lactation. We sought all randomized controlled trials, reported in any language, that included any form of hormonal contraception compared with another form of hormonal contraception, nonhormonal contraception or placebo during lactation. Seven reports from five randomized controlled trials met the inclusion criteria. Most of the five trials did not specify their method used to generate a random sequence, method of allocation concealment, blinding of treatments or use of an intention-to-treat analysis. Additionally, high loss-to-follow-up rates invalidated at least two trials. The findings from two trials comparing oral contraceptives to placebo during lactation were conflicting. Another trial found no inhibitory effects on lactation from progestin-only contraceptives. Finally, the World Health Organization trial found a statistically significant decline in breast milk volume in women using combined oral contraceptives compared to women using progestin-only pills. However, infant growth for the two groups did not differ. The limited evidence from randomized controlled trials on the effect of hormonal contraceptives during lactation is of poor quality and insufficient to establish an effect of hormonal contraception, if any, on milk quality and quantity. At least one properly conducted randomized controlled trial of adequate size is urgently needed to make recommendations regarding hormonal contraceptive use for lactating women.

Contraceptives, Oral, Combined↗

PubMed2002

Nearly half of dental randomized controlled trials published in German are not included in Medline.

Randomized controlled trials (RCTs) are considered the most reliable type of clinical intervention studies. However, not all reports of RCTs are accessible in Medline. This can impede the validity of the results of systematic reviews. Ten German-language dental journals were manually searched to locate reports of controlled clinical trials published between 1970 and 2000. The publication type was determined and compared with Medline. Of the 15 777 articles, 210 reports of RCTs and 410 articles of non-randomized controlled clinical trials (CCTs) were identified. Only 56% of the RCTs and 75% of the CCTs are available in Medline. Of the 118 reports of RCTs registered in Medline. 15 are indexed with the correct Publication Type term. Our data suggest that (a) hand-searching plays a valuable role in identifying reports of clinical dental trials, and (b) a literature search in Medline is likely to yield incomplete results.

Dental Research↗

PubMed1998

The comparative effects of postoperative analgesic therapies on pulmonary outcome: cumulative meta-analyses of randomized, controlled trials.

UNLABELLED: We performed meta-analyses of randomized, control trials to assess the effects of seven analgesic therapies on postoperative pulmonary function after a variety of procedures: epidural opioid, epidural local anesthetic, epidural opioid with local anesthetic, thoracic versus lumbar epidural opioid, intercostal nerve block, wound infiltration with local anesthetic, and intrapleural local anesthetic. Measures of forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), vital capacity (VC), peak expiratory flow rate (PEFR), PaO2, and incidence of atelectasis, pulmonary infection, and pulmonary complications overall were analyzed. Compared with systemic opioids, epidural opioids decreased the incidence of atelectasis (risk ratio [RR] 0.53, 95% confidence interval [CI] 0.33-0.85) and had a weak tendency to reduce the incidence of pulmonary infections (RR 0.53, 95% CI 0.18-1.53) and pulmonary complications overall (RR 0.51, 95% CI 0.20-1.33). Epidural local anesthetics increased PaO2 (difference 4.56 mm Hg, 95% CI 0.058-9.075) and decreased the incidence of pulmonary infections (RR 0.36, 95% CI 0.21-0.65) and pulmonary complications overall (RR 0.58, 95% CI 0.42-0.80) compared with systemic opioids. Intercostal nerve blockade tends to improve pulmonary outcome measures (incidence of atelectasis: RR 0.65, 95% CI 0.27-1.57, incidence of pulmonary complications overall: RR 0.47, 95% CI 0.18-1.22), but these differences did not achieve statistical significance. There were no clinically or statistically significant differences in the surrogate measures of pulmonary function (FEV1, FVC, and PEFR). These analyses support the utility of epidural analgesia for reducing postoperative pulmonary morbidity but do not support the use of surrogate measures of pulmonary outcome as predictors or determinants of pulmonary morbidity in postoperative patients. IMPLICATIONS: When individual trials are unable to produce significant results, it is often because of insufficient patient numbers. It may be impossible for a single institution to study enough patients. Meta-analysis is a useful tool for combining the data from multiple trials to increase the patient numbers. These meta-analyses confirm that postoperative epidural pain control can significantly decrease the incidence of pulmonary morbidity.

Administration, Oral↗

PubMed1992

Geriatric follow-up by home visits after discharge from hospital: a randomized controlled trial.

The aim of this prospective, randomized and controlled trial was to carry out and evaluate a model for follow-up by home visits after discharge from hospital of persons aged 75 years or more. The trial was a feasibility study in which hospital staff, district nurses, and general practitioners already working within the hospital and the primary health sector participated, with changes in the usual organization. On the day after their discharge from hospital, 163 patients were visited in their homes by the district nurse. Two weeks later, they were evaluated at home by their general practitioner. For 181 control patients, discharge took place according to the usual procedures. Endpoints were evaluated one year after discharge. Significantly more patients from the control group had been admitted to nursing homes as compared with the trial group (25/10, p < 0.05); the control patients stayed 2700 days at institutions, the trial group 1950 days. It is proposed that this simple and practicable follow-up routine be introduced in connection with discharge of elderly persons from hospital.

Aged↗

PubMed2006

Effect of folic acid supplementation on risk of cardiovascular diseases: a meta-analysis of randomized controlled trials.

CONTEXT: Epidemiologic studies have suggested that folate intake decreases risk of cardiovascular diseases. However, the results of randomized controlled trials on dietary supplementation with folic acid to date have been inconsistent. OBJECTIVE: To evaluate the effects of folic acid supplementation on risk of cardiovascular diseases and all-cause mortality in randomized controlled trials among persons with preexisting cardiovascular or renal disease. DATA SOURCES: Studies were retrieved by searching MEDLINE (January 1966-July 2006) using the Medical Subject Headings cardiovascular disease, coronary disease, coronary thrombosis, myocardial ischemia, coronary stenosis, coronary restenosis, cerebrovascular accident, randomized controlled trial, clinical trials, homofolic acid, and folic acid, and the text words folic acid and folate. Bibliographies of all retrieved articles were also searched, and experts in the field were contacted. STUDY SELECTION: From 165 relevant retrieved reports, 12 randomized controlled trials compared folic acid supplementation with either placebo or usual care for a minimum duration of 6 months and with clinical cardiovascular disease events reported as an end point. DATA EXTRACTION: Data on study design, characteristics of participants, changes in homocysteine levels, and cardiovascular disease outcomes were independently abstracted by 2 investigators using a standardized protocol. DATA SYNTHESIS: Studies including data from 16 958 participants with preexisting vascular disease were analyzed using a random-effects model. The overall relative risks (95% confidence intervals) of outcomes for patients treated with folic acid supplementation compared with controls were 0.95 (0.88-1.03) for cardiovascular diseases, 1.04 (0.92-1.17) for coronary heart disease, 0.86 (0.71-1.04) for stroke, and 0.96 (0.88-1.04) for all-cause mortality. The relative risk was consistent among participants with preexisting cardiovascular or renal disease. CONCLUSIONS: Folic acid supplementation has not been shown to reduce risk of cardiovascular diseases or all-cause mortality among participants with prior history of vascular disease. Several ongoing trials with large sample sizes might provide a definitive answer to this important clinical and public health question.

Cardiovascular Diseases↗

PubMedDate not supplied

Assessing the validity of published randomized controlled trials in podiatric medical journals.

The purposes of this study were to develop an instrument to assess the validity of randomized controlled trials and to report on the differences in the validity of randomized controlled trials between two podiatric medical journals and a mainstream medical journal. The study demonstrated that after adequate training, there can be agreement among reviewers evaluating the quality of published randomized controlled trials using an established instrument and guidelines. The results of the study indicate that randomized controlled trials published in podiatric medical journals are less credible than those published in a mainstream medical journal.

Humans↗

PubMed1997

Discrepancies between meta-analyses and subsequent large randomized, controlled trials.

BACKGROUND: Meta-analyses are now widely used to provide evidence to support clinical strategies. However, large randomized, controlled trials are considered the gold standard in evaluating the efficacy of clinical interventions. METHODS: We compared the results of large randomized, controlled trials (involving 1000 patients or more) that were published in four journals (the New England Journal of Medicine, the Lancet, the Annals of Internal Medicine, and the Journal of the American Medical Association) with the results of meta-analyses published earlier on the same topics. Regarding the principal and secondary outcomes, we judged whether the findings of the randomized trials agreed with those of the corresponding meta-analyses, and we determined whether the study results were positive (indicating that treatment improved the outcome) or negative (indicating that the outcome with treatment was the same or worse than without it) at the conventional level of statistical significance (P<0.05). RESULTS: We identified 12 large randomized, controlled trials and 19 meta-analyses addressing the same questions. For a total of 40 primary and secondary outcomes, agreement between the meta-analyses and the large clinical trials was only fair (kappa= 0.35; 95 percent confidence interval, 0.06 to 0.64). The positive predictive value of the meta-analyses was 68 percent, and the negative predictive value 67 percent. However, the difference in point estimates between the randomized trials and the meta-analyses was statistically significant for only 5 of the 40 comparisons (12 percent). Furthermore, in each case of disagreement a statistically significant effect of treatment was found by one method, whereas no statistically significant effect was found by the other. CONCLUSIONS: The outcomes of the 12 large randomized, controlled trials that we studied were not predicted accurately 35 percent of the time by the meta-analyses published previously on the same topics.

Humans↗

PubMed1989

Succinylcholine and atropine for premedication of the newborn infant before nasotracheal intubation: a randomized, controlled trial.

Twenty preterm newborn infants were randomized to receive either atropine alone (20 micrograms/kg) or atropine plus succinylcholine (2 mg/kg) before nasotracheal intubation. Heart rate, BP, transcutaneous PO2, and intracranial pressure were monitored continuously before, during, and after intubation. No infants developed bradycardia or hypoxia. Intracranial hypertension developed during intubation in the infants receiving atropine alone, but was prevented by premedication with succinylcholine and atropine (p less than .01). A 41% increase in systemic BP occurred immediately after the administration of succinylcholine (p less than .01). BP increased during intubation in both groups, and the overall peak BP was not significantly different between the groups. Intubation was significantly shorter in the infants receiving succinylcholine. Premedication with succinylcholine and atropine will facilitate intubation of neonates, and ameliorate the adverse physiologic consequences of this procedure.

Atropine↗