Professional Drug Information > Chloral Hydrate

Chloral Hydrate (Systemic)

VA CLASSIFICATION
Primary: CN309


Note: Controlled substance in the U.S.

Commonly used brand name(s): Aquachloral Supprettes; Novo-Chlorhydrate; PMS-Chloral Hydrate.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Sedative-hypnotic—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Anesthesia, adjunct—Chloral hydrate is indicated preoperatively to relieve anxiety and produce sedation and/or sleep ^{{05} {09} {10} {11}}.

[Sedation for procedures in pediatric patients]—Chloral hydrate is used to produce sedation in pediatric patients for certain dental ^{{02} {29} {30} {31}} and medical procedures ^{{16} {17} {18} {19} {20} {21} {22} {23} {24} {25} {26} {27} {28} {35}}.

—Chloral hydrate has been used for the treatment of insomnia ^{{09} {10} {11}}. However, this medication is effective as a hypnotic only for short-term use; it has been shown to lose its effectiveness for both inducing and maintaining sleep after 2 weeks of administration. In addition, chloral hydrate generally has been replaced by agents with better pharmacokinetic and pharmacodynamic profiles. ^{36}

—Chloral hydrate has been used as a routine sedative. However, it generally has been replaced by safer and more effective agents.

—Chloral hydrate also has been used as an adjunct to opiates and analgesics in postoperative care and control of pain ^{{05} {10} {11}}. However, it generally has been replaced by agents with better pharmacokinetic and pharmacodynamic profiles ^{36}.

Unaccepted
Chloral hydrate is not recommended for use in infants and children when repetitive dosing would be necessary ^{15}. With repeated dosing, accumulation of the trichloroethanol and trichloroacetic acid metabolites may increase the potential for excessive CNS depression ^{33}, predispose neonates to conjugated and nonconjugated hyperbilirubinemia ^{{33} {34}}, decrease albumin binding of bilirubin ^{33}, and contribute to metabolic acidosis ^{33}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    165.40 ^{03}

Mechanism of action/Effect:

The central nervous system (CNS) depressant effects of chloral hydrate are believed to be due to its active metabolite trichloroethanol. The mechanism of action is not known. ^{{05} {10} {11}}

Absorption:

Readily absorbed from the gastrointestinal tract, following oral administration ^{{05} {10}}.

Protein binding:

Trichloroethanol (the active metabolite)—35 to 41% ^{06}.

Biotransformation:

Chloral hydrate is metabolized in the liver and erythrocytes to the active metabolite trichloroethanol, which may be further metabolized to inactive metabolites. It is also metabolized directly to inactive metabolites by the liver and kidneys. ^{{05} {09} {38}}

Half-life:

The plasma half-life of trichloroethanol, the active metabolite, is about 7 to 10 hours ^{{05} {09}}.

Onset of action:

Oral—Within 30 minutes.

Duration of action:

About 4 to 8 hours.

Elimination:
    Renal; approximately 40% of dose excreted in 24 hours ^{{06} {09}}.


Precautions to Consider

Carcinogenicity/Mutagenicity

Long-term studies in animals have not been done ^{{05} {10}}.

Pregnancy/Reproduction

Pregnancy—
Chloral hydrate crosses the placenta. Studies on teratogenicity have not been done in humans. ^{{05} {09} {10} {11}} Chronic use of chloral hydrate during pregnancy may cause withdrawal symptoms in the neonate ^{{05} {10} {11}}.

Studies on teratogenicity have not been done in animals ^{{05} {09} {10} {11}}.

FDA Pregnancy Category C.

Breast-feeding

Chloral hydrate is distributed into breast milk; use by nursing mothers may cause sedation in the infant ^{{05} {09} {10} {11}}.

Pediatrics

Appropriate studies on the relationship of age to the effects of chloral hydrate have not been performed in the pediatric population. Deaths have occurred prior to or following diagnostic or therapeutic procedures, particularly in pediatric patients, after chloral hydrate was administered to induce sedation before the procedure ^{{41} {42} {45}}. The current Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation For Diagnostic and Therapeutic Procedures established by the American Academy of Pediatrics recommend that sedatives be administered only at the health care facility, where appropriate monitoring can be instituted. Monitoring must continue until the child's level of consciousness has returned to a state that meets appropriate approved discharge criteria. ^{14} In addition, particular care must be taken in calculating and administering the proper dose appropriate to the age and weight of pediatric patients ^{15}. Also, children with sleep apnea, especially obstructive sleep apnea with tonsillar hypertrophy, are particularly prone to respiratory compromise ^{{40} {42} {43} {46}}.

Chloral hydrate is not recommended for use in infants and children when repetitive dosing would be necessary ^{15}. With repeated dosing, accumulation of the trichloroethanol and trichloroacetic acid metabolites may increase the potential for excessive CNS depression ^{33}, predispose neonates to conjugated and nonconjugated hyperbilirubinemia ^{{33} {34}}, decrease albumin binding of bilirubin ^{33}, and contribute to metabolic acidosis ^{33}.


Geriatrics


No information is available on the relationship of age to the effects of chloral hydrate in geriatric patients. However, elderly patients are more likely to have age-related hepatic function impairment and renal function impairment, which may require reduction of dosage in patients receiving chloral hydrate.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Addictive medications, other, especially CNS depressants with habituating potential    (prolonged concurrent use may increase the risk of habituation; caution is recommended ^{07})


» Alcohol or
» CNS depression–producing medications, other (See Appendix II )    (concurrent use may increase the CNS depressant effects of either these medications or chloral hydrate; caution is recommended and dosage of one or both agents should be reduced ^{{05} {07} {09} {10} {11} {12} {13}})


» Anticoagulants, coumarin- or indandione-derivative    (hypoprothrombinemic effects may be increased when these medications are used concurrently with chloral hydrate, particularly during the first 2 weeks of concurrent therapy, because of displacement of the anticoagulant from its plasma protein binding sites; with continued concurrent use, anticoagulant activity may return to baseline level or be decreased; frequent prothrombin-time determinations may be required, especially during initiation of chloral hydrate therapy, to determine if dosage adjustment of the anticoagulant is necessary ^{{05} {07} {09} {10} {11} {12} {13}})


Furosemide, intravenous    (administration of chloral hydrate followed by intravenous furosemide within 24 hours ^{09} may result in diaphoresis, hot flashes, and variable blood pressure, including hypertension, due to a hypermetabolic state caused by displacement of thyroxine from its bound state ^{{05} {07} {09} {10} {12} {13}})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Fluorometric tests for urine catecholamines    (it is recommended that chloral hydrate not be administered for 48 hours preceding the test ^{{05} {09} {10}})


Glucose, urine    (determinations may give false-positive test results with Benedict's solution, and possibly with cupric sulfate tablets, but not with glucose enzymatic tests ^{{05} {09} {10}})


Phentolamine test    (chloral hydrate may cause false-positive phentolamine test; it is recommended that all medications be withdrawn at least 24 hours, preferably 48 to 72 hours, prior to a phentolamine test ^{05})


Urinary 17-hydroxycorticosteroid determinations    (when using the Reddy, Jenkins, and Thorn procedure ^{{05} {09} {10}})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Cardiac disease, severe^{{01}{05}{09}{10}{11}}    (condition may be exacerbated by large doses of chloral hydrate ^{01})


Alcohol abuse or dependence, history of or
Drug abuse or dependence, history of^{05}{09}{11}    (dependence on chloral hydrate may develop)


» Esophagitis or
» Gastritis or
» Ulcers, gastric or duodenal    (condition may be exacerbated—for oral dosage forms only)

^{05}{09}
» Hepatic function impairment, severe    (chloral hydrate metabolized in liver ^{{05} {09} {10} {11}})


Porphyria, intermittent    (acute attacks may be precipitated by chloral hydrate ^{{05} {10}})


Proctitis or colitis    (condition may be exacerbated—for rectal dosage forms only)


» Renal function impairment, severe    (chloral hydrate excreted via kidneys ^{{05} {09} {10} {11}})


» Sleep apnea in pediatric patients (especially with tonsillar hypertrophy)^{40}{42}{46}    (increased risk of respiratory compromise)


Sensitivity to chloral hydrate


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Allergic reaction (skin rash or hives)^{{05}{09}{10}{11}}

Incidence rare
    
Confusion
    
paradoxical reaction (hallucinations; unusual excitement)^{10}
{05}


Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Nausea
    
stomach pain
    
vomiting
^{{05}{09}{10}{11}}
Incidence less frequent
    
Clumsiness or unsteadiness
    
diarrhea
    
dizziness or lightheadedness
    
drowsiness
    
``hangover'' effect
^{{05}{09}{10}{11}}


Those indicating possible withdrawal and the need for medical attention if they occur after medication is discontinued
    
Confusion
    
hallucinations
    
nausea or vomiting
    
nervousness
    
restlessness
    
stomach pain
    
trembling
    
unusual excitement
^{05}{09}{10}



Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
    
Confusion, continuing
    
convulsions
    
difficulty in swallowing
    
drowsiness, severe
    
low body temperature
    
nausea, vomiting, or stomach pain, severe
    
shortness of breath or troubled breathing
    
slow or irregular heartbeat
    
slurred speech
    
staggering
    
weakness, severe
^{05}{09}{10}
Note: Hepatic and renal function may be impaired, resulting in transient jaundice and albuminuria during recovery from chloral hydrate overdose ^{09}.



Treatment of overdose
Treatment of chloral hydrate overdose consists of the following: ^{{05} {09} {10}}


To decrease absorption:
Gastric lavage following oral overdose (endotracheal tube with inflated cuff should be in place to prevent aspiration of vomitus).



To enhance elimination:
Hemodialysis may be effective in promoting the clearance of trichloroethanol.



Monitoring:
Continuous cardiac monitoring is important, especially in patients with predisposing cardiac disease.



Supportive care:
Support of respiration and circulation.

Maintenance of normal body temperature.

Artificial respiration with oxygen may be required.

Appropriate fluid and electrolyte therapy should be administered and an adequate urinary output maintained.

Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Chloral Hydrate (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to chloral hydrate

Pregnancy—Chloral hydrate crosses placenta; chronic use during pregnancy may cause withdrawal symptoms in neonate





Breast-feeding—Chloral hydrate is distributed into breast milk; use by nursing mothers may cause sedation in the infant
Other medications, especially alcohol or other CNS depression–producing medications or coumarin- or indandione-derivative anticoagulants
Other medical problems, especially esophagitis, gastritis, gastric or duodenal ulcers, hepatic function impairment, renal function impairment, or sleep apnea in children, especially with tonsillar hypertrophy

Proper use of this medication
» Importance of not using more medication than the amount prescribed because of habit-forming potential

Proper administration
For capsule dosage formSwallowing capsule whole; not chewing because of unpleasant taste

Taking with a full glass (240 mL) of water, fruit juice, or ginger ale to reduce gastric irritation

For syrup dosage formTaking each dose mixed with clear liquid (e.g., water, apple juice, ginger ale) to improve flavor and reduce gastric irritation

For suppository dosage formProper administration technique

Chilling in refrigerator for 30 minutes or running cold water over suppository before removing foil wrapper if too soft for insertion

» Proper dosing
Missed dose: Not taking missed dose; not doubling doses

» Proper storage

Precautions while using this medication
Regular visits to physician to check progress during prolonged therapy

Checking with physician before discontinuing medication after prolonged use; gradual dosage reduction may be necessary to avoid the possibility of withdrawal symptoms

» Avoiding use of alcohol or other CNS depressants

» Suspected overdose: Getting emergency help at once

» Caution if dizziness, lightheadedness, or drowsiness occurs


Side/adverse effects
Signs of potential side effects, especially allergic reaction, confusion, and paradoxical reaction


General Dosing Information
Deaths have occurred prior to or following diagnostic or therapeutic procedures, particularly in pediatric patients, after chloral hydrate was administered to induce sedation before the procedure ^{{41} {42} {45}}. The current Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation For Diagnostic and Therapeutic Procedures established by the American Academy of Pediatrics recommend that sedatives be administered only at the health care facility, where appropriate monitoring can be instituted. Monitoring must continue until the child's level of consciousness has returned to a state that meets appropriate approved discharge criteria. ^{14} In addition, particular care must be taken in calculating and administering the proper dose appropriate to the age and weight of pediatric patients ^{15}.

Use of chloral hydrate in infants and children is not recommended when repetitive dosing would be necessary ^{15}.

Children with sleep apnea, especially obstructive sleep apnea with tonsillar hypertrophy, are particularly prone to respiratory compromise ^{{40} {42} {43} {46}}.

Tolerance may develop by the second week of continual administration ^{{05} {11}}.

Prolonged use of larger than usual therapeutic doses may result in psychic or physical dependence ^{{05} {09} {10}}.

Following prolonged administration, chloral hydrate should be withdrawn gradually in order to avoid the possibility of precipitating withdrawal symptoms ^{{05} {09} {10}}.

For oral dosage forms only
Chloral hydrate capsules should be administered with a full glass (240 mL) of water, fruit juice, or ginger ale to reduce gastric irritation ^{{05} {09} {10}}.

Each dose of chloral hydrate syrup should be diluted in clear liquid (e.g., water, apple juice, ginger ale) to improve flavor and reduce gastric irritation ^{{05} {09} {10} {36} {44}}.

In patients with gastritis, oral chloral hydrate preparations may be dissolved in olive oil or cottonseed oil and administered rectally.


Oral Dosage Forms

CHLORAL HYDRATE CAPSULES USP

Usual adult dose
Sedative-hypnotic


Hypnotic:
Oral, 500 mg to 1 gram fifteen to thirty minutes before bedtime ^{{05} {09}}.



Sedative:
Daytime—Oral, 250 mg three times a day after meals ^{{05} {09}}.

Preoperative—Oral, 500 mg to 1 gram thirty minutes before surgery.



Usual adult prescribing limits
Up to 2 grams daily ^{{05} {09}}.

Usual pediatric dose
Sedative-hypnotic
Premedication prior to dental or medical procedures: Oral, 50 mg per kg of body weight ^{32}, up to a maximum of 1 gram per single dose ^{{05} {09} {15}}. Doses of 25 to 100 mg per kg of body weight may be used in individual patients ^{{15} {16} {17} {18} {19} {20} {21} {22} {23} {25} {27} {28} {29} {30} {31} {37}}. The total dose should not exceed 100 mg per kg of body weight or 2 grams ^{{19} {24} {30} {37} {39}}.

Premedication prior to electroencephalographic evaluation: Oral, 25 mg per kg of body weight ^{{05} {09} {15}}.

Note: Deaths have occurred prior to or following diagnostic or therapeutic procedures, particularly in pediatric patients, after chloral hydrate was administered to induce sedation before the procedure ^{{41} {42} {45}}. The current Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation For Diagnostic and Therapeutic Procedures established by the American Academy of Pediatrics recommend that sedatives be administered only at the health care facility, where appropriate monitoring can be instituted. Monitoring must continue until the child has returned to the presedation level of consciousness or meets appropriate approved discharge criteria. ^{14} In addition, particular care must be taken in calculating and administering the proper dose appropriate to the age and weight of pediatric patients ^{15}.



Strength(s) usually available
U.S.—


250 mg (Rx)[Generic]


500 mg (Rx)[Generic]

Canada—


500 mg (Rx) [Novo-Chlorhydrate]

Packaging and storage:
Store between 15 and 30 °C (59 and 86 °F), in a tight container ^{04}.

Stability:
Clarity of the capsules may vary without affecting the potency ^{04}.

Auxiliary labeling:
   • Swallow capsules whole.
   • Avoid alcoholic beverages.
   • May cause drowsiness.
   • Keep container tightly closed.

Note: Controlled substance in the U.S.



CHLORAL HYDRATE SYRUP USP

Usual adult dose
See Chloral Hydrate Capsules USP .

Usual adult prescribing limits
See Chloral Hydrate Capsules USP.

Usual pediatric dose
See Chloral Hydrate Capsules USP.

Strength(s) usually available
U.S.—


250 mg per 5 mL (Rx)[Generic]


500 mg per 5 mL (Rx)[Generic]

Canada—


500 mg per 5 mL (Rx) [PMS-Chloral Hydrate][Generic]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing. ^{04}

Auxiliary labeling:
   • Avoid alcoholic beverages.
   • May cause drowsiness.

Note: Controlled substance in the U.S.




Rectal Dosage Forms

CHLORAL HYDRATE SUPPOSITORIES

Usual adult dose
Sedative-hypnotic
Hypnotic: Rectal, 500 mg to 1 gram as a single dose at bedtime ^{{06} {11}}.

Sedative: Rectal, 325 mg three times a day ^{11}.


Usual adult prescribing limits
Up to 2 grams daily ^{{06} {11}}.

Usual pediatric dose
Sedative-hypnotic
Premedication prior to dental or medical procedures: Rectal, 50 mg per kg of body weight ^{32}, up to a maximum of 1 gram per single dose ^{{05} {09} {15}}. Doses of 25 to 100 mg per kg of body weight may be used in individual patients ^{{15} {16} {17} {18} {19} {20} {21} {22} {23} {25} {27} {28} {29} {30} {31} {37}}. The total dose should not exceed 100 mg per kg of body weight or 2 grams ^{{19} {24} {30} {37} {39}}.

Premedication prior to electroencephalographic evaluation: Rectal, 25 mg per kg of body weight ^{{05} {09} {15}}.

Note: Deaths have occurred prior to or following diagnostic or therapeutic procedures, particularly in pediatric patients, after chloral hydrate was administered to induce sedation before the procedure ^{{41} {42} {45}}. The current Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation For Diagnostic and Therapeutic Procedures established by the American Academy of Pediatrics recommend that sedatives be administered only at the health care facility, where appropriate monitoring can be instituted. Monitoring must continue until the child has returned to the presedation level of consciousness or meets appropriate approved discharge criteria. ^{14} In addition, particular care must be taken in calculating and administering the proper dose appropriate to the age and weight of pediatric patients ^{15}.



Strength(s) usually available
U.S.—


325 mg (Rx) [Aquachloral Supprettes (tartrazine)]


500 mg (Rx)[Generic]


650 mg (Rx) [Aquachloral Supprettes (tartrazine)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer ^{04}.

Auxiliary labeling:
   • For rectal use only.
   • Avoid alcoholic beverages.
   • May cause drowsiness.

Note: Controlled substance in the U.S.

Revised: 03/31/1995

References

1. Noctec (Squibb). In: Physicians' desk reference. 40th ed. 1986. Oradell, NJ: Medical Economics Company, 1986: 1754.
   

2. Indications Index Review comment.
   

3. Fleeger CA, editor. USAN 1984. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1983: 137.
   

4. The United States pharmacopeia. The national formulary. USP 21st revision (January 1, 1985). NF 16th ed (January 1, 1985). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1985.
   

5. Noctec package insert (Squibb—US), Rev 12/86, Rec 5/87.
   

6. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1986: 270d.
   

7. USP DI 1988.
   

8. Panel 14 recommendation (at panel mtg 2/88).
   

9. Generic Chloral Hydrate Capsules package insert (West-Ward—US), Rev 9/87, Rec 3/89.
   

10. Noctec Capsules & Syrup package insert (Squibb—US), Rev 12/86, Rec 3/89.
    

11. Aquachloral Supprettes package insert (Alcon-Puerto Rico—US), Rev 1/88, Rec 11/88.
    

12. Shinn AF, Shrewsbury RP. EDI, Evaluation of drug interactions. 3rd ed. St Louis: Mosby, 1985: 134, 158, 535, 544, 594, 605.
    

13. Hansten PD, Horn JR. Drug interactions. 6th ed. Philadelphia: Lea & Febiger, 1989: 78, 296, 312.
    

14. American Academy of Pediatrics, Committee on Drugs. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics 1992 Jun; 89(6): 1110-5.
    

15. Pediatrics Advisory Panel Meeting, 10/30/93.
    

16. Greenberg SB, Faerber EN, Aspinall CL, Adams RC. High-dose chloral hydrate sedation for children undergoing MR imaging: Safety and efficacy in relation to age. Am J Roentgenol 1993 Sep; 161 (3): 639-41.
    

17. Cook BA, Bass JW, Nomizu S, Alexander ME. Sedation of children for technical procedures: Current standard of practice. Clin Pediatr 1992 Mar; 137-42.
    

18. Ronchera CL, Marti-Bonmati L, Poyatos C, Vilar J, Jimenez NV. Administration of oral chloral hydrate to paediatric patients undergoing magnetic resonance imaging. Pharmacetutisch Weekblad Scientific edition 1992; 14(6): 349-52.
    

19. Greenberg SB, Faerber EN, Aspinall CL. High dose chloral hydrate sedation for children undergoing CT. J Comput Assist Tomogr 1991 May-Jun; 15(3): 467-9.
    

20. Rumm PD, Takao RT, Fox DJ, Atkinson SW. Efficacy of sedation of children with chloral hydrate. South Med J 1990 Sep; 83(9): 1040-3.
    

21. Cremin BJ. Sedation for CT examinations in children [letter]. Br J Radiol 1990 Apr: 316.
    

22. Strain JD, Harvey LA, Foley LC, Campbell JB. Intravenously administered pentobarbital sodium for sedation in pediatric CT. Radiology 1986; 161: 105-8.
    

23. Koch RL. Chloral hydrate as a sedative in children during imaging procedures [letter]. Radiology 1984 Dec; 153(3): 833.
    

24. Thompson JR, Schneider S, Ashwal S, Holden BS, Hinshaw DB Jr, Hasso AN. The choice of sedation for computed tomography in children: A prospective evaluation. Radiology 1982 May; 143: 475-9.
    

25. Neuman GG, Kushins LG, Ferrante S. Sedation for children undergoing magnetic resonance imaging and computed tomography [letter]. Anesth Analg 1992: 74: 931-2.
    

26. Fisher DM, Zwass MS. Chloral hydrate administration to children [letter]. Anesth Analg 1993; 76: 668-9.
    

27. Neuman GG, Kushins LG, Ferrante S. Chloral hydrate administration to children [letter response]. Anesth Analg 1993; 76: 668-9.
    

28. Fox BES, O'Brien CO, Kangas KJ, Murphree AL, Wright KW. Use of high dose chloral hydrate for ophthalmic exams in children: A retrospective review of 302 cases. J Pediatr Ophthalmol Strabismus 1990 Sep/Oct; 27(5): 242-4.
    

29. Moore PA, Mickey EA, Hargreaves JA, Needleman HL. Sedation in pediatric dentistry: a practical assessment procedure. J Am Dent Assoc 1984 Oct; 109(4): 564-9.
    

30. Brandt SK, Bugg JL Jr. Problems of medication with the pediatric patient. Dent Clin North Am 1984 Jul; 28(3): 563-79.
    

31. Houpt M. Report of project USAP: The use of sedative agents in pediatric dentistry. ASDC J Dent Child 1989 Jul-Aug; 56(4): 302-9.
    

32. Lichenstein R, King JC, Bice D. Evaluation of chloral hydrate for pediatric sedation. Clin Pediatr 1993 Oct: 632-3.
    

33. American Academy of Pediatrics Committee on Drugs and Committee on Environmental Health: Use of chloral hydrate for sedation in children. Pediatr 1993 Sep; 92(3): 471-3.
    

34. Steinberg AD. Should chloral hydrate be banned? Pediatr 1993 Sep; 92(3): 442-6.
    

35. Panel comment, 4/7/94.
    

36. Reviewers' consensus on monograph revision of 3/23/94.
    

37. Cote CJ. Sedation for the pediatric patient. A review. Pediatr Clin North Am 1994 Feb; 41 (1): 31-58.
    

38. Panel comment, 4/20/94.
    

39. Badgwell JM. Anesthesia and analgesia for minor injuries to children. Int Anesthesiol Clin Win 94; 32(1): 123-47.
    

40. Personal communication, 5/26/94.
    

41. Personal communication, 8/2/94.
    

42. Pediatric Advisory Panel Meeting, 10/18/94.
    

43. Biban P, Baraldi E, Pettenazzo A, et al. Adverse effect of chloral hydrate in two young children with obstructive sleep apnea. Pediatr 1993 Sep; 92: 461-3.
    

44. Reviewers' consensus on monograph revision of 11/21/94.
    

45. Chloral hydrate overdoses result in childrens' deaths. USP Drug Product Quality Review. 1993 Feb; No. 33.
    

46. Panel comment, 12/94.
    

Link to Page

Print Page

Email Page