Study of Morphine in Postoperative Infants to Allow Normal Ventilation
OBJECTIVES: I. Compare nonmechanically ventilated infants who receive morphine postoperatively as intermittent intravenous bolus doses or as a continuous intravenous infusion targeted to reach a steady-state concentration.
II. Assess ventilation (blood gases, continuous oximetry, and CO2 response curves) and analgesia (infant pain score) between the two treatment groups of infants.
III. Compare ventilation parameters (blood gases, CO2 response curves, and time to wean from assisted mechanical ventilation) in cyanotic and acyanotic infants after thoracotomies.
調査の概要
詳細な説明
PROTOCOL OUTLINE: This is a two part study. Infants are stratified by age (1-30 days vs 31-180 days vs 181-365 days) and by type of surgery. Infants are randomly assigned to one of two treatment arms.
In part I, following major thoracic, abdominal, or cardiac surgery, infants are randomized to receive either continuous IV morphine infusions (arm I) or to receive morphine by single IV bolus doses every 2-3 hours (arm II).
In part II, cyanotic and acyanotic infants following thoracotomy receive morphine by 2 loading doses over 15 minutes and then by continuous IV infusion.
Patients are followed for at least 2 days.
Completion date provided represents the completion date of the grant per OOPD records
研究の種類
入学
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Infants scheduled for surgery with postoperative inpatient care
- Must be born after 35 weeks or more gestational age
- No prenatal opiate exposure
Part I patients:
- Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures
- No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects)
- No hepatic or renal transplantation
Part II patients:
- Less than 3 months of age undergoing surgeries using a thoracotomy approach
- Cyanotic congenital heart disease having palliative systemic to pulmonary artery shunts created OR Thoracotomy for repair of acyanotic lesions (e.g., repairs of coarctation of the aorta, tracheoesophageal fistula repair, PDA ligation)
--Patient Characteristics--
- Age: Part I: Less than 12 months Part II: Less than 3 months
- Hepatic: Normal hepatic function tests
- Renal: Normal renal function tests
- Pulmonary: No pulmonary disease causing baseline hypercarbia
- No pulmonary hypertension contraindicating use of 5% CO2 in rebreathing studies
Other:
- No allergy to morphine
- No severe developmental delay that precludes analgesia scoring
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 割り当て:ランダム化
協力者と研究者
捜査官
- スタディチェア:Anne M. Lynn、Seattle Children's Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 199/13359
- CHMC-S-FDR001015
- CHMC-S-IRB-022-9801
- CHMC-S-IRB-148-9706
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
痛みの臨床試験
-
Dexa Medica Group完了